The Best Regulatory Compliance Freelancers For Hire In India

Check out Regulatory Compliance Freelancers in India with the skills you need for your next job.

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$40 hourly
- 5.0/5
- (4 jobs)
With over 8 years of experience in the industry, I am a seasoned QARA professional specializing in quality management systems and regulatory compliance. Here is a brief overview of my proficiency and background. - Specialization in ISO 13485 and 21 CFR-compliant Quality Management Systems for medical device manufacturers. I have set up the QMS for 6 medical device manufacturers to date. - Regulatory Markets: Support regulatory compliance across India, the US, the UK, and Europeon market. Plan and support 510(K) approvals. - MDR 2017/745 services for CE certification: Provide MDR services such as clinical evaluation and post-market surveillance for over 40 medical devices. - Audit Excellence: Certified internal auditor, adept at comprehensive audits for continuous improvement. -Hands-on experience with project management: I have successfully led a team of 30 individuals through the intricacies of a product development program (Software+Hardware). Some of the International clients I have worked with are; CIRCA Scientific MC3 Corp Varex Imaging Asensus Surgical Channel Medsystems Morair Medtech Micrima Limited Better Medicine NeuroMagnetics Australia

Regulatory Compliance
Drug Regulation
Biotechnology Regulation
Medical Device User Manual
Internal Auditing
Software Documentation
Software Development
Software
Quality Management System
Quality Assurance
Quality Control
Technical Writing
Project Risk Management
Scientific Research
Medical Device
Scientific Writing
Technical Documentation
$45 hourly
- 4.8/5
- (45 jobs)
I am a Product Safety Specialist having extensive experience in the field of Product Certification(CE marking/CE Certification/regulatory compliance). If these are the services that you require, I can promise that you are in safe hands for an end to end solution right from carrying out a Product Analysis, preparing a Conformity Assessment procedure, compiling a Technical File leading to drafting the Declaration of Conformity. About myself, I am a Mechanical Engineer with an MBA (Operations) and a Bachelor in Law. I have worked with several Manufacturing, Consulting and Certification agencies during my 30 years tenure. I am very knowledgeable about the various European Directives, Standards & conformity assessment procedures, Risk Assessment studies etc., I support various clients for products falling under Machinery, Low Voltage, Electromagnetic Compatibility, RED, ROHS, Construction Products Regulation and others. Also familiar with other Directives such as ATEX, PPE, PED, Medical Device etc., I have worked with Certification Bodies such as Bureau Veritas, TUV Rheinland and TUV Nord for a span of 17 years. I am therefore confident of supporting my clients for their various requirements. I have supported companies for Certification of : CNC Machines, IoT products, Consumer & Electronic products, Beverage Dispensers, Control Panels, , Material Handling Equipment, Data Loggers, 3D Metal Printers, Gear hobbing and grinding machines, Card sorters, Sheet Metal Press, Motors, Pumps, Alternators, Transformers, Test Rigs, Hydraulic Power Packs, Glass Lifting Machines, Automatic Voltage Regulator, Valves and many more. I am very active on Upwork and have rendered services for my Clients located in USA, Australia and various parts of Europe. During my career, I have rendered services to Globally renowned companies such as ABB, Bosch, Liebherr, Millipore, Biozeen, Atlas Copco, Sandvik, Weir Group, Nagel Special Machines, Yuken, Schenck Group, Mann & Hummel, Murugappa Group, Micromatic Grinding Group, Triveni Engineering and many more.

Regulatory Compliance
Risk Analysis
Technical Documentation
Regulatory Intelligence
Product Documentation
Compliance
Legal Consulting
Compliance Consultation
Product Label
Safety Assessment
Medical Device
Risk Assessment
Label Compliance
Product Listings
$15 hourly
- 5.0/5
- (38 jobs)
I am a highly skilled Company Secretary from India, similar to Corporate/Chartered Secretary, with over 8+ years of experience in Corporate Laws, Commercial Agreements Drafting, Taxation, Cross-Border Fund raising, Formation of Different Business Entities (In USA, India, UAE), Handling Alternate Dispute Resolutions (Arbitration and Mediation), Intellectual Property Rights, Legal Research and so on. My Services Include (But are not limited to): 📈Legal Consultancy Services: (a) Corporate Laws (b) Bankruptcy and Insolvency Law (c) Securities and Financial Laws (d) Intellectual Property Rights (e) Taxation Laws (f) US Corporate Law (e) Technology Laws (f) Cyber Laws and Data Privacy Laws (GDPR, Data Protection) 📈Corporate Laws/Taxation: (a) Drafting of Founder's Agreement/Shareholders Agreement (b) USA/India Tax Preparation and reporting (c) Compliances in respect to all Corporate Actions of business entities in USA/India. (d) Tax Advisory (e) Filing of Tax Returns (f) Franchisee tax 📈Business Entity Formation: (a) Formation of a C-Corp, LLC, Partnership, elect to as S-Corp in USA and any form of business entity in India. (b) Formation of Company in Singapore (Pte Ltd.) (c) Drafting and filing of Article of Formation (Incorporation) (d) Drafting and filing of By-Laws 📈Contract Drafting and Reviewing:: (a) Review & Drafting of Legal Documents, including, but not limited to, Title/Conveyance Deed, Mortgage Deed, Power of Attorney, Corporate Resolutions, Corporate By-laws, Promissory Note, Affidavit, Product Warranty, Will, Trust Deed/Document (b) Review & Drafting of Litigation Documents, including, but not limited to, Legal Notice/Lawyer's Letter, Cease & Desist Notice, Plaint, Complaint, Statement of Claim, Answer to Plaint/Complaint or Statement of Claim, Motion, Response in opposition to Motion (c) Joint Venture Agreements, Cross-Border Investment Agreements, IP Assignment Agreements, Commercial Contracts, Confidentiality Agreement, Memorandum of Understanding, (d) Drafting of Terms & Conditions and Privacy Policy for Website and Mobile Applications in compliance with GDPR and other Internationals regulations such as CCPA , End-user License Agreement (EULA), Software as a Service (SaaS) Agreement, Marketing Services Agreement, Professional Services Agreement, Consultancy Agreement, SEO Service Agreement, Franchise Agreement, LLC Membership Interest Purchase Agreement, Partnership Agreement, Employment Contract, Company Property Rental Agreement, Independent Contractor Hiring Agreement, Share Transfer Agreement, Share Purchase Agreement, IP/Copyright Assignment Agreement, Lease Agreement, Loan Agreement, Confidentiality & Non-Disclosure Agreement (NDA) etc. (e) Legal translation and proof-reading; 📈Intellectual Property related services: (a) Trade Mark/ Copyright Registration including prior public search and consultation (b )Drafting and filing replies/ responses to notice from Trade Mark registry and appearing before the registry for prosecuting the Trade Mark application. I am looking forward to work with the dynamic professionals as freelancer, understand their requirement and help them with my expertise. Thank You for visiting my profile.

Regulatory Compliance
Tax Planning & Advisory
Certified Tax Preparer
Legal Writing
Contract Drafting
Legal Assistance
Intellectual Property Law
Legal Research
Limited Liability Company
Corporate Law
Tax Law Compliance
S-Corporation
Legal Agreement
C-Corporation
Tax Return
$25 hourly
- 5.0/5
- (15 jobs)
As a freelance lawyer with over 9 years of industry experience, I specialize in a wide range of legal areas including tech, corporate, contract, real estate/property and employment law. With a deep understanding of the legal issues facing businesses and individuals in these areas, I provide clients with customized legal solutions designed to help them achieve their goals and navigate complex legal challenges. In the tech space, I have worked with a variety of clients ranging from startups to established businesses, providing legal guidance and support on a range of issues including software licensing agreements, intellectual property protection, and data privacy and security. I understand the unique legal challenges facing tech companies and have the expertise to help clients navigate this complex landscape. In the corporate space, I have assisted clients with entity formation, compliance, and governance, as well as contract drafting and review. I work closely with clients to understand their unique needs and goals, and provide tailored legal solutions designed to help them achieve success. In addition to my experience in tech and corporate law, I have also developed a strong skillset in contract law, with expertise in drafting and negotiating a wide variety of contracts including employment agreements, service agreements, and licensing agreements. Whether you need assistance with drafting, reviewing, or negotiating contracts, I have the skills and expertise to help. Some of the services I provide include: - Contract drafting and review - Drafting of Terms of Service for Websites and Mobile Apps - Drafting of Privacy Policies in compliance with GDPR/DPA/CCPA,CPRA. - Intellectual property protection - Legal Research - Employment law guidance and support - Entity formation, compliance, and governance - Litigation support and dispute resolution - Regulatory compliance - Property/Real-Estate legal advise In addition to my legal expertise, I also offer paralegal services to assist clients with legal research, drafting legal documents, and providing administrative support. If you're looking for a reliable, experienced, and results-driven legal professional, look no further. Contact me today to discuss how I can help you with your legal needs.

Regulatory Compliance
Property Law
Real Estate Law
Legal Consulting
Legal Writing
Legal Research
Law
Legal Drafting
Corporate Law
Employment Law
Contract Law
Contract Negotiation
Contract Drafting
Legal
$20 hourly
- 4.9/5
- (17 jobs)
In my capacity as a distinguished legal professional and paralegal, I am driven by an ardent zeal for adeptly navigating the intricate legal terrain of commerce and enterprise. With a well-documented history of furnishing sagacious counsel to corporations, enterprising visionaries, and discerning executives, I bring forth a treasury of experience coupled with an unerring eye for minutiae to each legal endeavor. Over the course of my career, I have artfully refined my proficiency in contract negotiation, mergers and acquisitions, corporate governance, and compliance. In every undertaking, I steadfastly prioritize the protection of my clients' interests while adhering unwaveringly to the loftiest echelons of ethical standards. It is through my unwavering commitment to crafting bespoke legal solutions, coupled with my perspicacity in preempting potential risks, that I have garnered the trust and admiration of a diverse clientele spanning an array of industries. My core areas of Legal Expertise include but are not strictly confined to: 🎯Legal Research: - Digital personal data protection bill -E-stamping regulations -MLM (Multi-Level Marketing) Regulations - POSH (Prevention of Sexual Harassment) Compliance - Corporate Law - Insolvency and Bankruptcy Code (IBC) - Corporate Governance -Data Privacy and Protection - Regulatory Compliance - Website Compliances -Start-up Compliances 🎯 Contract Drafting: - NDA -Banking Agreements - Merchant Service Agreement -Service Provider -Referral agreement -White-Labelled Agreements -Sub-Merchant Agreement -SAAS, -Channel Partner, -Exit Agreement -Service Level Agreement // SOW // Work Order - Memorandum of Understanding (MOUs) -Partnership Agreements -Shareholder Agreements -Joint Venture Agreements -Licensing Agreements -Employment Contracts - Consulting Agreements -Sales and Distribution Agreements -Lease Agreements (Commercial and Residential) -Franchise Agreements -Supply Agreements -Marketing Agreements -Agency Agreements -Outsourcing Agreements -Software Licensing and Development Agreements -Research and Development Agreements -Indemnity Agreements -Release and Waiver Agreements -Confidentiality Agreements -Intellectual Property Assignment Agreements 🎯Other Areas of Expertise (Policy Drafting): - KYC (Know Your Customer) Policy -AML (Anti-Money Laundering) Policy -Privacy Policy -Terms of Use Policy - Data Governance Policy - Data Retention and Disposal Policy - POSH (Prevention of Sexual Harassment) Policy - Equal Employment Opportunity Policy - Retrenchment Policy - E&S (Environment and Sustainability) Policy - Information Security Policy - Data Protection Policy - Confidentiality Policy - Code of Conduct Policy - Whistleblower Policy - Social Media Policy - Remote Work Policy - Health and Safety Policy - Intellectual Property Policy - Diversity and Inclusion Policy - Employee Benefits Policy - Anti-Bribery and Corruption Policy - Conflict of Interest Policy - Grievance Redressal Policy - Compliance and Ethics Policy - Supplier Code of Conduct Policy - Crisis Management Policy - Travel and Expense Policy - Records Management Policy - Environmental Policy

Regulatory Compliance
Legal Research
SaaS
FinTech Consulting
Service Level Agreement
Escrow Agreement
Privacy Policy
Legal Consulting
Contract Negotiation
Startup Consulting
Terms & Conditions
Contract
Contract Drafting
Partnership Agreement
Non-Disclosure Agreement
$15 hourly
- 4.2/5
- (55 jobs)
Welcome to a hub where engineering acumen meets healthcare innovation. I'm a dedicated biomedical engineering graduate from Hiroshima University, driven by a mission to merge the precision of engineering with the dynamic world of medical technology. My goal? To craft cost-effective, cutting-edge solutions that enhance healthcare quality and accessibility. My expertise is a blend of rigorous engineering research and a deep understanding of Med Tech's complexities. With a toolkit sharpened by hands-on experience in MATLAB, OpenSim, and biomechanics, I thrive on transforming concepts into tangible outcomes that push the frontiers of healthcare. Areas of Expertise: 🛠️ Biomedical Engineering: From biomaterials to medical device design, my foundation is solid and ready for innovation. ✍️ Research & Writing: Whether it’s a meticulous literature review, insightful article critique, or comprehensive thesis writing, I can articulate complex ideas with clarity and precision. 💡 Product Development: Navigating from proof of concept to polished prototype, I'm well-versed in the intricacies of product design, aligned with ISO 13485, 21 CFR 820 standards. 📊 Data Mastery: My proficiency in data analysis and entry is complemented by a robust knowledge of Excel, COMSOL, and MATLAB. Special Interests: 📈 Data Entry & Analysis: I revel in turning data into decisions, with a keen interest in biomechanics and signal processing. 🎛️ Hardware & Software: Arduino and image processing are within my domain, merging software skills with hardware haptics. 📝 SEO & Technical Writing: Crafting content that ranks and resonates, from technical documentation to SEO-driven articles. As a freelancer, I'm more than a list of skills—I'm a partner in your project's journey. I bring passion, time management, and unwavering commitment to every task. My project management agility spans JIRA to Monday.com, ensuring that milestones are met with efficiency and excellence. I have strong background in Literature review, Market research, SEO infused technical content writing. Need translation services? Fluent in a linguistic array that includes Tamil, Japanese, Chinese, Spanish, Korean, Hindi, and Indonesian, I bridge communication gaps with ease. Let's collaborate to create healthcare solutions that matter. Ready when you are!

Regulatory Compliance
Content Writing
Scientific Research
Technical Editing
Quality Assurance
Medical Device
Data Scraping
Microsoft Excel
Technical Writing
Data Entry
Article
Microsoft Word
$80 hourly
- 4.5/5
- (3 jobs)
An accomplished, versatile, results-oriented Medical cum Technical Writer professional with over 16 years of experience in the Pharmaceuticals & Medical Device industries who brings strong all aspects of a Medical cum Technical Writing. Experience includes Medical Writing for both domestic and international markets for the Medical Device and Pharmaceuticals Industry, cross-functional leadership, and outstanding value proposition development and delivery as a leader in organizations of varying size and complexity. Ensuring compliance with the local regulatory, ICH-GCP, MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, EU IVDR 2017/746, ISO- 14155, ISO10993-1, SaMD, NIOSH Submission, SOPs, and any other applicable regulations. Medical Writing Includes (Clinical Evaluation Report (CER), Biological Safety Evaluation, Biocompatibility, IVD PER, Trial Protocol, PMCF, PMS, CIP, ICF, CSR, IB, PSUR, DSUR, PBRER, Manuscripts, Journal Articles, Literatures Systematic Review Analysis, Meta-Analysis and Scientific Documents).

Regulatory Compliance
Quality Assurance
Drug Regulation
Medical Device
$70 hourly
- 4.9/5
- (13 jobs)
Hi there! I’m Raghav, a former lawyer turned tech expert who’s passionate about making work easier and more efficient through AI-powered automation and no-code tools. With a unique blend of legal industry experience and technical expertise, I specialize in crafting solutions that simplify workflows, save time, and boost productivity—whether you're managing case files in a law firm or streamlining operations for your growing business. Here’s what I can help you with: 1. AI Agents to automate routine tasks 2. Workflow Automation to save time and resources 3. Custom Dashboards for managing operations 4. Document Automation & Review for legal and business needs 5. Sales & Marketing Automation to drive growth I believe in delivering tailored solutions that fit your unique needs—no one-size-fits-all templates here. Whether you’re a legal professional or an entrepreneur looking to scale, I’m here to help you focus on what matters most while I handle the technical grind. Let’s work together to transform how you work! Skills: 1. AI Agent Development 2. No-Code Platforms (Glide, Zapier, Make/Integromat) 3. Workflow & Process Automation 4. Legal Tech Solutions (Document Automation, Case Management) 5. Data Management Tools 6. Sales & Marketing Automation Portfolio Highlights: 1. Built an AI-powered lead management system for a SaaS company 2. Developed a custom CRM to streamline operations for a small business 3. Automated document drafting and review processes for corporate lawyers 4. Designed a client intake system for a boutique law firm 5. Created a compliance workflow automation for a healthcare law firm

Regulatory Compliance
Legal
Compliance
Usability Testing
Product Management
Minimum Viable Product
Wireframing
Prototyping
Squarespace
Wix
Design Writing
Analytics Plugin
$35 hourly
- 4.8/5
- (14 jobs)
Hello, I'm Sk Morsadul Anam, a distinguished professional specializing in Computer System Validation and compliance within the realms of GxP, ISO 9001, ISO 27001, and ISO 13485 standards. With an impressive 12-year tenure in the field, I've honed my expertise in ensuring the reliability, compliance, and efficiency of computer systems. Key Skills: Computer System Validation: Proficient in validating computer systems for various industries. GxP Compliance: Ensuring adherence to Good Practices in industries like pharmaceuticals and healthcare. GMP (Good Manufacturing Practices): Expertise in maintaining quality standards in manufacturing processes. SOP Writing: Craftsmanship in developing clear and effective Standard Operating Procedures. 21 CFR Part 11 Compliance: Adept at implementing electronic record-keeping and electronic signatures. ISO 9001, ISO 27001, and ISO 13485 Standards: Comprehensive knowledge and experience in implementing and maintaining these international standards. My Expertise: My extensive experience includes successfully guiding organizations through complex compliance processes. I have a proven ability to design and implement effective validation strategies, ensuring seamless integration with industry regulations and standards. Whether it's GxP compliance, SOP development, or navigating the intricacies of ISO standards, I provide tailored solutions for each unique challenge. Why Choose Me? Proven Track Record: Demonstrated success in validating systems and ensuring compliance. Comprehensive Expertise: Adept at navigating GxP, GMP, SOPs, and ISO standards. Quality Assurance: Dedicated to upholding the highest standards of quality in every project. Regulatory Adherence: Commitment to ensuring compliance with 21 CFR Part 11 and other relevant regulations. Collaborative Approach: Ready to collaborate closely to understand your specific needs and deliver customized solutions. Let's embark on a collaborative journey to enhance the compliance, efficiency, and reliability of your computer systems. I'm here to contribute my wealth of experience to drive your success in the highly regulated landscape.

Regulatory Compliance
Medical Device
Compliance Testing
Quality Management System
Quality Assurance
Quality Audit
CSV
Technical Documentation
Software Testing
Software QA
Functional Testing
Good Manufacturing Practice
IT Compliance Audit
Pharmaceutical Industry
$60 hourly
- 4.9/5
- (8 jobs)
Expertise in compilation/review of CMC sections (CTD Module 1 to 3)/Cosmetic PIF dossier. Registered 500+ products in global markets. 13+ years of experience in Global Regulatory Affairs. Worked as consultant for Fortune 500 clients (J&J, Pfizer). Completed post graduation from one of the premier institute in India.

Regulatory Compliance
Retail & Consumer Goods
Cosmetics
Pharmaceuticals
Cosmetic Raw Materials
Pharmaceutical Industry
Cosmetic Regulation
$20 hourly
- 5.0/5
- (7 jobs)
I am a seasoned consultant and expert in Computer System Validation (CSV), Computer System Assurance (CSA), Quality Assurance, and Regulatory Compliance, with over 15 years of experience in the pharmaceutical industry. My extensive background includes: Regulatory Compliance: I have successfully navigated complex regulatory requirements, ensuring adherence to standards set by FDA, EMA, and other global health authorities. My deep understanding of regulatory frameworks has consistently guided companies through complex audits and inspections. Quality Assurance: I specialize in creating, reviewing, and maintaining comprehensive documentation that meets all regulatory expectations. This includes developing validation plans, protocols, and reports to ensure compliance with current Good Manufacturing Practices (cGMP) and Good Automated Manufacturing Practice (GAMP) guidelines. Computer System Validation (CSV): With solid experience in CSV for GxP critical systems, I am well-versed in regulatory standards such as US FDA 21 CFR Part 11, EU EudraLex Annex 11, ISPE GAMP5, US FDA 21 CFR Part 820, and ICH Q10. I have validated various software and applications, including SAP modules, CMMS, PharmaSync, and Automated Logic’s WebCTRL. Computer System Assurance (CSA) : I specialize in risk-based validation, streamlined compliance strategies, and data integrity for GxP-regulated computerized systems in the pharmaceutical industry. Adept at implementing CSA principles to enhance system efficiency, maintain regulatory compliance, and ensure product quality and patient safety. Throughout my career, I have developed and executed validation strategies, conducted risk assessments, and managed remediation projects with a detail-oriented approach. My commitment to excellence and passion for upholding the highest standards of regulatory compliance have earned me a reputation as a trusted advisor in the industry. Services I provide include: Computer System Validation: Validating new or updated software, databases, and computer systems as per 21 CFR requirements. Part 11 Assessments: Assessing the compliance status of your computer systems. Process and Equipment Validation: Ensuring all controlled systems and processes are compliant with relevant regulations. QMS Documentation and Regulatory Writing: Expertise in writing regulatory content, technical articles, Sops for Pharma and blog posts. I have worked with a diverse range of clients, from small biotech startups to large multinational pharmaceutical companies, helping them achieve and maintain compliance throughout the product life-cycle. My experience includes leading cross-functional teams, conducting training sessions, and mentoring junior staff to build robust compliance cultures within organizations. Pharmaceutical SOP Expertise I specialize in developing and implementing Standard Operating Procedures (SOPs) for the pharmaceutical industry. My expertise ensures compliance with regulatory standards and optimizes operational efficiency. Key areas include: Material Handling: Quality verification and proper storage conditions. Production Processes: Detailed batch records and equipment maintenance. Quality Control: In-process checks and final product testing. Packaging and Labeling: Contamination prevention and accurate labeling. Documentation: Comprehensive record-keeping and document control. I ensure consistent high-quality production and regulatory adherence, enhancing overall pharmaceutical manufacturing practices. Contact me today to discuss your regulatory compliance, computer system validation (CSV), QMS document development, and SOP writing needs. Let's embark on a journey toward pharmaceutical excellence together. Additionally, I specialize in the synthesis of pharmaceutical impurities, metabolites, reference standards, working standards, isotope-labeled (deuterated) compounds, and intermediates for both R&D and commercial purposes.

Regulatory Compliance
Software Testing
Functional Testing
Quality Assurance
Good Manufacturing Practice
Quality Audit
Software Consultation
IT Compliance Audit
Technical Documentation
Software QA
API Documentation
Compliance Consultation
Quality Management System
Drug Regulation
Pharmaceutical Industry
$50 hourly
- 0.0/5
- (1 job)
I am a professional Chartered Accountant from India with more than 5 years of experience. I have been associated with Moore Stephens India. My experience in providing Management Consulting services to various MNCs including Financial Securities Valuation, Tax advisory, Company Formation, etc. will be of great help in providing services to you.

Regulatory Compliance
Microsoft Excel
Financial Modeling
Management Skills
Leadership Skills
CPA
Tax Law
Business Consulting
Business Valuation
Valuation
Company Valuation
Financial Analysis
$15 hourly
- 4.7/5
- (13 jobs)
★ 5+ years of experience ★ 5 Stars rating and reviews received Over 5 years experience in Regulatory Affairs, V&V and technical submissions for a range of medical devices, including orthopaedics, active implantable and novel, high-risk electromechanical systems. Responsible for authoring several 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, biocompatibilty reporting, process validations, labeling and packaging etc). Similarly, have authored several technical files and design dossiers for CE marking of Class IIa, IIb and Class III devices. Handled all subsequent follow-ups and questions from Notified Bodies, including on-site audits from both the FDA and BSI. Participated in pres-sub activities with the FDA for novel high-risk implants in the design phase, to establish regulatory pathway to First In-Human trials and subsequent PMA. Achieved and maintained registration of products in a range of jurisdictions including EU, US, Canada, Australia, Israel, Chile and Japan. Familiar with the application of a range of standards including ISO 13485, ISO 14971, IEC 60601, FDA 21 CFR Part 820, as well as upcoming changes in the new EU MDR. Well versed in the development and lodgement of Regulatory Files, and can complete activities such as literature searches, clinical evaluations ,predicate device comparisons, development of SOP's and other QMS documentation, as well as validations for processes such as sterilization (gamma and EtO), packaging, and Human Factors Engineering studies. I look forward to working with you! Thanks!

Regulatory Compliance
Quality Management System
Medical Writing
$15 hourly
- 4.9/5
- (8 jobs)
Seasoned Management systems expert with expertise in all management systems (ISO 9001, ISO 45001, ISO 14001, ISO 27001), statistics, Risk Management, HSE management system, ITIL, CMMI Certified Six Sigma Blackbelt and have executed more than 25 Six sigma projects successfully across different industries. Expertise in Quality Management System spread across different industries and companies operating in versatile enviornments.

Regulatory Compliance
Risk Analysis
Statistical Process Control
ISO 9000
Financial Audit
Strategic Plan
Project Management
Lean Manufacturing
Risk Assessment
Project Risk Management
Lean Consulting
Six Sigma
Process Improvement
Data Analysis
Statistics
$30 hourly
- 5.0/5
- (2 jobs)
- Focused & Competent Pharmaceutical Health care professional with about 15 years of experience. - Expertise in New Product development (Solid Orals, Liquids, Nasal Sprays) from project initiation, development, regulatory queries and launch to market. - Analytical Project lead for R & D and expert in method development, method validation, method transfer to local and global sites, - Acted as Quality professional & DQA in various aspects as implementation of GQP/QMS, Quality agreements, CAPA’s, Change Controls, Audit exposure (GQA/CQA/USFDA). - Hands on Various Data Management systems. expert in writing technical documentation. - Expert responses to auditors’ queries without any observations. - Hands on experience of Computer system Validation and its entire life cycle. - New Infrastructure facility, Equipment & Software for GmP release. - Expert in Nasal Spray Characterization. - Equipment Validation Life Cycle.

Regulatory Compliance
Academic Writing
Microsoft Excel
Scientific Research
Online Research
Company Research
Research Documentation
Document Review
Quality Assurance
QA Management
Quality Control
Product Development
Research & Development
$10 hourly
- 5.0/5
- (1 job)
Greetings! I am a qualified legal practitioner based in India, specialising in providing comprehensive legal solutions to companies, startups, and individuals worldwide. With over 3 years of experience in the legal field, I bring a wealth of expertise in legal research, writing, contract drafting, due diligence, and regulatory compliance. ⭐𝐖𝐡𝐚𝐭 𝐈 𝐂𝐚𝐧 𝐇𝐞𝐥𝐩 𝐘𝐨𝐮 𝐖𝐢𝐭𝐡⭐ ✨𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 & 𝗖𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗲 𝗖𝗼𝗻𝘁𝗿𝗮𝗰𝘁𝘀: MOUs, NDAs, Service Agreements etc. ✨𝗜𝗣 & 𝗠𝗲𝗱𝗶𝗮 𝗟𝗮𝘄 𝗔𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁𝘀: Copyright Assignments, Non-Disclosure Agreements, Licenses etc. ✨𝗪𝗲𝗯𝘀𝗶𝘁𝗲 𝗿𝗲𝗹𝗮𝘁𝗲𝗱 𝗔𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁𝘀 & 𝗣𝗼𝗹𝗶𝗰𝗶𝗲𝘀: Terms of Service, Privacy Policies, E-Commerce Policies etc. ✨𝗘𝗺𝗽𝗹𝗼𝘆𝗺𝗲𝗻𝘁 𝗔𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁𝘀: Non-Compete Agreements, Confidentiality Agreements, Severance Agreements etc. ✨𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗔𝗴𝗿𝗲𝗲𝗺𝗲𝗻𝘁𝘀 & 𝗣𝗼𝗹𝗶𝗰𝗶𝗲𝘀: Software Licenses, SaaS Agreements, Data Protection Policies etc. ✨𝗟𝗲𝗴𝗮𝗹 𝗡𝗼𝘁𝗶𝗰𝗲𝘀: Demand Letters, Cease and Desist Notices, Breach of Contract Notices etc. ⭐𝐖𝐡𝐲 𝐂𝐡𝐨𝐨𝐬𝐞 𝐌𝐞?⭐ 🔍 𝗔𝘁𝘁𝗲𝗻𝘁𝗶𝗼𝗻 𝘁𝗼 𝗗𝗲𝘁𝗮𝗶𝗹: - I thrive on the intricacies of legal work, ensuring no detail goes unnoticed. - Precision in documentation to mitigate potential risks. ✅ 𝗛𝗶𝗴𝗵-𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝗮𝗯𝗹𝗲𝘀: - Commitment to delivering top-notch legal services. - I can provide services at the required quality and am available to make changes as requested. 🤝 𝗖𝗹𝗶𝗲𝗻𝘁 𝗦𝗮𝘁𝗶𝘀𝗳𝗮𝗰𝘁𝗶𝗼𝗻: 👍 Your satisfaction is my priority; I am dedicated to meeting your expectations. ⏳ I value your time and deliver projects on schedule. ✍️ Open communication for a collaborative and transparent process. ✅ All work that I perform for my clients is confidential. 𝐏𝐚𝐬𝐬𝐢𝐨𝐧𝐚𝐭𝐞 𝐚𝐛𝐨𝐮𝐭 𝐋𝐚𝐰, 𝐂𝐨𝐦𝐦𝐢𝐭𝐭𝐞𝐝 𝐭𝐨 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞: I am not just a legal practitioner; I am passionate about the law. Every case is an opportunity to apply my expertise and contribute to the success of my clients. Let's work together to navigate the legal intricacies and achieve your objectives. 𝙇𝙚𝙩'𝙨 𝙘𝙤𝙣𝙣𝙚𝙘𝙩 𝙛𝙤𝙧 𝙖 𝙛𝙧𝙚𝙚 𝙘𝙤𝙣𝙨𝙪𝙡𝙩𝙖𝙩𝙞𝙤𝙣 𝙖𝙣𝙙 𝙙𝙞𝙨𝙘𝙪𝙨𝙨 𝙝𝙤𝙬 𝙄 𝙘𝙖𝙣 𝙝𝙚𝙡𝙥 𝙮𝙤𝙪 𝙖𝙘𝙝𝙞𝙚𝙫𝙚 𝙮𝙤𝙪𝙧 𝙜𝙤𝙖𝙡𝙨.

Regulatory Compliance
Tech & IT
Legal Agreement
Terms & Conditions
Privacy Policy
Corporate Law
Contract Law
Legal
Legal Consulting
Legal Assistance
Legal Drafting
Due Diligence
Contract Drafting
Legal Writing
Legal Research
$25 hourly
- 5.0/5
- (5 jobs)
I’m a Certified Anti-Money Laundering Specialists and Six Sigma Black-Belt, specializing in the AML, KYC Remediation, On-boarding, Due-Diligence and risks assessments. Over the course of 15 years in this sphere, I have handled many complex cases, risks assessment and successfully managed the compliance culture of the organization. During my time in this role, I have managed KYC remediation, On-boarding Customers, Risks Assessments, Transaction Monitoring and prevent financial crimes. Among my colleagues, I am known as a tenacious go-getter. I set challenging goals and I make sure my team have the capabilities to meet them. Specialties: Anti-Money Laundering, Prevent Financial Crimes, KYC Remediation, Transaction Monitoring, Customer On-boarding, Due Diligence, Risks Assessments, Team Building, Staff Management, Regulatory Compliance.

Regulatory Compliance
Internal Control
Due Diligence
Know Your Customer
Data Entry
Policy Writing
Compliance Consultation
Compliance
Anti-Money Laundering
GDPR
FinTech Consulting
Risk Assessment
Data Protection
Microsoft Word
$15 hourly
- 5.0/5
- (1 job)
I have over 7 years of experience in Computerized System Validation and software testing, in the Medical Devices, Healthcare, and Life Sciences domains. I have executed projects based on GAMP 5 in adherence with 21 CFR Part 11, with expertise in the Validation process, Regulatory Risk assessment, business and functional requirement analysis, comprehensive test scenario creation, and test execution. Having authored processes and templates for creating a QMS, which is now ISO 13485: 2016 certified, I enjoy accelerating implementations to reduce the time to market for my clients. Key Skills:  Computer system validation (prospective) for GAMP category 4 and 5 systems, for one of top 3 pharmaceutical companies and Retrospective Validation of an array of GAMP category 1, 3, 4, and 5 products, effective 340 remediation.  High-quality Validation Plans/ Reports, IQ, OQ, and PQ test scenarios and scripts, creation, and execution.  Proficient in the end to end validation process execution, including ERES and Risk Assessments with Standard Operating Procedures and Requirement authoring (User, Functional specifications, and Detail design documents)  ISO 13485:2016, 21 CFR Part 11 and 820, Sarbanes-Oxley (SOX), EU Annex 11, GAMP 5, and ITIL.  Generate and execute verification and validation (System Testing, IQ, OQ, PQ, UAT) documentation for GXP and non-GXP computerized systems such as IT infrastructure, R&D (Pre-Clinical/Clinical, Medical Affairs, Regulatory Affairs, Pharmacovigilance), Commercial (CRM), Quality (Labs, Labeling/Artwork, QMS, Change Management, Deviations & Investigations, Training), Finance, HR, Legal/Corporate Compliance) Key Achievements: • Successfully validated the integration of CTMS software i.e. IMPACT with MDM and deployed in PROD within desired timelines • Remediation project planning and implementation for closure of audit findings with comprehensive CAPA and efficient Change management. • Test scenario creation, involving positive and challenge testing, based on functional risk assessment. Data Migration plan author and Test planning lead for Integration. • QMS author at the organizational level

Regulatory Compliance
Test Case Design
Database Testing
Test Management
White Box Testing
Risk Assessment
Regression Testing
CSV
Agile Project Management
Jira
$10 hourly
- 5.0/5
- (1 job)
I am legal consultant from India with 10+ years of experience in the fields of Employment laws, HR Advisory, Corporate Laws, Employment contracts and HR policies. I am an experienced corporate Counsel with a demonstrated history of working with leading MNCs. I have worked on drafting employment documents including Employment contracts, Non-compete, non-disclosure and non-solicitation agreements, SOPs, HR Policies, Data Protection, corporate governance etc. I have also worked on reviewing service agreements, contract abstraction and vetting etc. Additionally, my experience lies in handling Employment litigations before labor courts, High courts in India. I can help you and your company with: ✔ Employment and Labour laws ✔ HR Policies formulation ✔ Employment agreements ✔ Regulatory risk ✔ non-Compete, non-Solicitation, non-Disclosure agreements. ✔ HR Policies formulation ✔ HR Advisory ✔ Legal Advisory ✔ Legal consultancy ✔ Contract Drafting I'm a diligent professional, like to do things on time and budget. So feel free to reach out for any of the relevant services.

Regulatory Compliance
Employee Onboarding
Employee Relations
Human Resources Strategy
Compliance
Human Resources Consulting
Human Resources Compliance
Employment Handbook
Legal Writing
HR Policy
Legal Consulting
Employment Dispute
Legal Drafting
Employment Law
Contract Drafting
$95 hourly
- 0.0/5
- (0 jobs)
Hello, Namaskar Everyone, Myself C.A. Aditya Kundlik Mali, I have cleared my CA Final Group 1 Exams in November 2022 & Group 2 exams in May 2023. So I am a qualified Chartered Accountant now. I have recently started out with my own CA Practice and now I am a proprietor at Aditya K Mali & Associates. I have completed my 3 years of articleship from Uttam Abuwala & Co. & A.D. Bhate & Co. in the various fields of Accountancy, Statutory Audit, Direct Taxation, Indirect Taxation & Project Finance. Apart from the above professional activities, I have a keen interest in the current affairs, General Knowledge. Also, I am a Defence Enthusiast as well. I love to read & hear about the tales of valor of our brave Indian Armed Forces & their less known military operations.

Regulatory Compliance
Tax Law
Tax Planning & Advisory
Tax Law Compliance
Financial Modeling
Financial Analysis
Finance & Accounting
International Taxation
Indirect Tax
Accounting Advisory
International Accounting Standards
Tax Return
Accounting
$40 hourly
- 0.0/5
- (0 jobs)
Hello, I'm Vedant Gupta, a seasoned professional with a background in finance, strategy, and leadership. With a track record of excellence and a wealth of experience in Mergers & Acquisitions, I bring a unique set of skills to the table that can help you achieve your business goals. Education: I hold a Post Graduate Program in Strategy and Leadership with a specialization in Finance from the prestigious Indian School of Business. During my academic journey, I emerged as a national finalist in various case competitions, showcasing my proficiency in consulting, marketing, finance, and strategy. This includes being a winner in competitions like "Next Up" and "Drawdown." Professional Experience: I've served as a Senior Manager at Ernst & Young, where I've managed a portfolio of 25+ transactions with a combined deal value exceeding $20 billion. My expertise lies in Mergers & Acquisitions, where I've engaged with top-level executives, prepared financial models, conducted valuations, and spearheaded project management. Notable achievements include being recognized as the 'Young Tax Professional of the Year 2018' and receiving multiple performance awards. I've played pivotal roles in marquee deals like the acquisition of Whitehat Jr. by Byju's and the acquisition of a stake in Fortis Healthcare by IHH Healthcare Berhad, among others. Additional Experience: During my tenure at NinjaCart, I managed a $25 million seed fund, invested in promising startups, and built internal processes for startup evaluation. My experience extends beyond finance, as I am an advocate for social initiatives and have actively supported underprivileged children in their education and professional development. Why Choose Me: With a strong foundation in finance, an exceptional track record, and a commitment to making a positive impact, I am well-equipped to assist you in a wide range of projects. My dedication to excellence, problem-solving skills, and strategic mindset make me an ideal choice for your business needs.

Regulatory Compliance
Tax Planning & Advisory
Fund Accounting
Investment Banking
Legal Entity Structuring
Accounting
Venture Capital Consulting
Investment Research
Mergers & Acquisitions
$20 hourly
- 5.0/5
- (2 jobs)
I am a mortgage loan analyst experienced in Closing, Setup and origination, Rate Lock, Regulatory Compliance, Pipeline management, funding approval, and Secondary loan selling. Knows Loan estimates, Closing disclosures, closing packages, disclosures, pricing, etc. Also knows Excel, Power BI, Tableau, MySQL, R, and SAS.

Regulatory Compliance
Statistical Analysis
Tableau
Microsoft Power BI
Data Analysis
MySQL
Business Analysis
Loan Approval
Customer Support
Loan Processing
Microsoft Excel
$70 hourly
- 0.0/5
- (0 jobs)
Detail-oriented Mechanical Engineer with 6+ years of experience in designing and developing customized medical(Oral-Maxillofacial, Cranio-Maxillofacial and Orthopedic) implants and instruments using 3D Printing and Additive Manufacturing. Proficient in Medical Image Processing, Surgeon Liaison and quality assurance standards for healthcare products. Having good command over multiple CAD packages and medical software's helps to achieve output within controlled environment. Being a certified Lead Auditor for ISO 13485 quality standard, leveraging the understanding of regulatory concerns and delivering output with 98% on-time completion ratio. I have had privilege to work for huge heads in medical industries like Styker, Zimmer Biometric, OPM, VelmeniAi, ReluAi, C.A.R.P.L.Ai, SHALBY ADVANCED TECHNOLOGIES, Koobo Implants, ALM Ortho, Akunah, etc.... #blender #solidworks #materialisemimics #3dslicer #simpleware #meshmixer #customimplants #custominstruments #iso13485 #regulatory #leadauditor #3dprinting #medicalimagesegmentation #medicalimaging #virtualsurgicalplanning #digitalsurgery

Regulatory Compliance
Biology
3D Product Rendering
3D Printing
Lattice 3D Printing Structures
Medical Animation
3D Design
SolidWorks
Blender
Image Segmentation
Project Management
Product Development
AI-Enhanced Medical Imaging
Medical Imaging
Medical Device
$100 hourly
- 0.0/5
- (1 job)
 RAC (Drugs) from Regulatory Affairs Professionals Society, 2022  Contributed as an author to the RAPS book "Fundamentals of Pharmaceutical and Biologics Regulations - A Global Perspective"  RAPS Member and Volunteer for Regulatory Competency Framework Taskforce.  Good knowledge of ICH, OCED-GLP, 21 CFR 312 & 314, NDCT Rules 2019, EU Regulations and Pharmacovigilance.  Expertise in preparation of global regulatory strategies.  Submission of IND/CTA, NDA/MAA to global Regulatory Authorities.  Supported biosimilar programs including ADCs, MABs and associated NCEs registration in emerging markets.  Strong Regulatory Affairs skills, hardworking, reliable and able to rise to challenges with determination.  Experience in collaborating with people from different streams & Ability to work in complexity.

Regulatory Compliance
Quality Assurance
Biotechnology Regulation
Medical Device
Biology Consultation
Drug Regulation
Drug Discovery
Regulatory Intelligence
$70 hourly
- 0.0/5
- (0 jobs)
Professional Medical Writer | Scientific Researcher | Content Creator Hello! I’m a passionate and detail-oriented Medical Writer and Scientific Researcher with a strong foundation in pharmacy and healthcare. As a final-year B. Pharmacy student, I bring a unique blend of academic expertise and practical experience to create compelling, accurate, and research-driven content for a wide range of audiences. What I Offer: *Medical Writing: Crafting research-based articles, blogs, and reports on healthcare topics, medications, and treatment protocols. *Scientific Research: Conducting thorough research and summarizing complex scientific concepts in a clear and concise manner. *Content Creation: Developing educational materials, scripts, and infographics tailored to your target audience. *Regulatory Writing: Preparing professional regulatory documents, including clinical trial reports and SOPs. *Proofreading & Editing: Ensuring scientific accuracy, clarity, and compliance with medical writing standards. Why Work With Me? ✔ Expert Knowledge: My background in pharmacy equips me with a deep understanding of drugs, therapies, and healthcare topics. ✔ Clear Communication: I excel at translating technical information into content that’s easy to understand for both professionals and general audiences. ✔ Attention to Detail: Accuracy is my top priority, especially when it comes to medical and scientific writing. ✔ On-Time Delivery: I value your time and guarantee timely delivery without compromising quality. Industries I Serve: Pharmaceuticals Healthcare & Wellness Academic & Scientific Research E-learning Platforms Let’s Collaborate! I am here to help bring your ideas to life with precise, engaging, and impactful content. Whether you need articles, research papers, or educational materials, I’m excited to assist. Let’s create something incredible together! Feel free to reach out—I look forward to working with you!

Regulatory Compliance
Chemistry
Research Paper Writing
Pharmaceutical Industry
Analytical Chemistry
Healthcare Management
Data Analysis
Editing & Proofreading
Research Papers
Technical Writing
Article Writing
Academic Writing
Content Writing
Scientific Research
Medical Writing
$100 hourly
- 0.0/5
- (0 jobs)
- Proven experience in developing and implementing privacy strategies for tech products (social media products) in India. Alignment of legal approach with global product strategies - Strong understanding of unique regulatory landscapes for data privacy not just in India, but across APAC. Demonstrated expertise on India's evolving privacy regulations - Expertise in creating and executing intricate and customized privacy readiness programs to bring client into compliance with APAC's data protection laws - Skilled in managing wide breadth of cross-functional stakeholders, proven record of securing alignment and partnerships with both, external as well as internal stakeholders to navigate complex regulatory and product related issues

Regulatory Compliance
Privacy
Legal
Strategy
Legal Consulting
Data Protection Act
Data Protection
Public Policy
Privacy Impact Assessment
Privacy Law
$30 hourly
- 5.0/5
- (4 jobs)
My Name is Supriya Kadam and I have a total experience of over 5 years in the field of medical device Quality and Regulatory services.Throughout my career, I have successfully managed medical device regulatory projects (CE Certificate, MDSAP Certifications, ISO 13485 Certifications, Gap analysis etc) for various organizations. Being a certified Internal Auditor, i assess the actual status of the Quality Management System of various medical device manufacturing company. And verify that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of Regulatory Requirements.

Regulatory Compliance
Quality Management System
Quality Audit
Quality Assurance
Medical Device
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