Hire the Best Regulatory Compliance Freelancers
in India

I’m Dr. Abhijath Murali Pharm.D (BCMAS, RAPS-certified, PMP) - A Top Rated Plus Freelancer with 100k+ earnings from Upwork with cross-functional experience at IQVIA, Cipla, IPCA, and Accenture. Past Experience : - I am having 8+ years of combined experience in Regulatory Affairs + Clinical Research + Medical Affairs - guiding sponsors from first-in-human to post-market. - I help in formulation of Dietary Supplements in US, EU, India. - I help biotech and pharma teams design inspection-ready studies, secure ethics approvals, and deliver submissions that move programs forward on time and audit-proof. - MDR/IVDR support, Clinical Evaluation Reports, Performance Evaluation Reports, and technical file documentation. - I perform Regulatory gap assessments, audit readiness, health authority response support, and compliance strategy. Expertise on : USFDA • EMA • CDSCO I support IND/CTA/NDA submissions, eCTD documentation, labeling compliance, QA workflows, and clinical writing across startups, CROs, and emerging biotech teams. My focus is delivering accurate, inspection‑ready documents that accelerate development timelines without compromising compliance. What I Deliver : - IND, CTA, NDA, and ANDA module writing, particularly for CTD Modules 2 to 5. - Submission Preparation : eCTD support (Modules 1–5) - Labelling : US Prescribing Information, SmPC, CCDS review, labeling compliance, and content alignment. - SOP development, QA documentation, CAPA logs - Regulatory Writing : Clinical writing: Protocols, IBs, CSRs, safety summaries - Regulatory intelligence & documentation QC - Variation Preparation & Renewal Analysis (US & EU) Why Clients Work With Me : - RAC (US,EU, Global) certified - Strong foundation in FDA, EMA, HC, and ICH frameworks - High accuracy, fast turnaround, and structured workflows - Experience validating regulatory datasets used in AI systems - Ability to produce submission‑ready content across drugs, biologics, and devices If you need support preparing a submission, reviewing labeling, drafting SOPs, or QC‑checking regulatory documents, I can step in immediately and deliver with precision. Send me a message with your project details - I typically respond within a few hours. Also, If your regulatory documentation needs to be ready for submission and not sent back for repeated revision, share your project brief. I can help turn complex regulatory content into a strong, well-structured submission package. Keywords : Regulatory Affairs • IND/IDE • 510(k) • SaMD • ICH-GCP • IRB • Clinical Trial Design • Protocol Development • Pharmacovigilance • Medical Writing • CSR • IB • EDC/CRF • EMA • CDSCO • US FDA • 505 b(1) • 505 b(2)

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!

Hi, I’m Mehul, a Top-Rated-Plus AWS Expert and DevOps Engineer who helps startups and founders launch and scale reliable SaaS, healthcare, and fintech platforms on AWS. ✅ Top 1% Upwork Freelancer ✅ 125+ Projects Completed ✅ 7000+ Hours Worked ✅ Top-Rated Plus on Upwork ✅ AWS Certified Developer - Associate 🏆 🏆 I’ve designed systems serving 2M+ users, built HIPAA-compliant healthcare apps, and helped teams cut cloud bills by 30–40 % without compromising performance. My focus is simple: build it once, make it scale, and keep your costs under control. ✅ What I Do ➥ Architect secure, serverless AWS setups using Lambda, API Gateway, and DynamoDB ➥ Deploy AI Agent to AWS with Bedrock ➥ Automate deployments with Terraform, GitHub Actions, and CodePipeline ➥ Optimise infrastructure for speed, uptime, and cost 💡 Why Work With Me ➥ 7+ years in AWS DevOps ➥ $300 K+ earned on Upwork, 100 % Job Success Known for clear communication, quick delivery, and long-term reliability Let’s connect if you’re building a product and want an AWS setup that’s secure, scalable, and easy to manage so you can focus on growing your business while I handle the cloud. Experienced with Amazon EC2, S3, RDS, Aurora, DynamoDB, ElastiCache, CloudFront, API Gateway, Step Functions, EKS, Fargate, CodePipeline, CodeBuild, CloudWatch, Grafana, Prometheus, GuardDuty, Security Hub, AWS Organisations, SCPs, KMS, Secrets Manager, IAM, WAF, Route53, ACM, Amplify, SageMaker, Bedrock, OpenSearch, and CloudFormation. Python, Bash, TypeScript, Node.js, Docker, Kubernetes, GitHub Actions, GitLab CI, Jenkins, n8n, Zapier.

I am a Regulatory and Quality Consultant with an expansive regulatory and quality experience with OTC drugs, Food Supplements, Cosmetic products, and medical devices. Over the last 20 years, I've held various senior level management positions within global companies. I started my career as an Analytical Chemist and held my most recent position in a QA / RA Consulting agency. I have experience in regulatory requirements for the US, EU, Canada, Australia, Singapore, Malaysia, Philippines, Taiwan, India, and other semi-regulated markets as well.! Some of my other specialties include product dossie authoring and review, technical files compilation , regulatory submissions, writing SOPs working in QMS (Overall Quality Management) environment and Systems that comply with ISO standards, and various worldwide regulatory entities. I am well-versed in research skills and good at regulatory intelligence too,! My Expertise and favorite thing is product compliance, product classification, and label compliance review. I can review your, OTC drug, Food Supplement, Food Products, and Cosmetic labels for compliance to the US FDA, EU Directives, Health Canada, and GCC countries Expert in Regulatory compliance for Cosmetic Products for regulated markets like US, EU, UK, China, Japan, Canada, Singapore, Malaysia, and India. - Cosmetic Product Classification, - Preparation of regulatory strategy for respective health authority, Labeling Compliance, Formulation Assessment for ingredients acceptability for restriction limits as per end use and end user. - Claims Assessment for acceptability and substantiation as per HA requirement. - Safety assessment for the cosmetic product. Review of Cosmetic Product Safety Report (CPSR). - Preparation of Production information file (PIF) file. - Product notification/registrations through CPNP, eCOSMA and MOCRA - FDA DIRECT portals. Worked on various product categories like Skin Care, Hair care, Pain care, and dermal care products, and worked on products like Aveeno, Neutrogena, Clean and Clear, Noskurf lotion, Triclenz, and Triflow for new market launch (GCC countries). Regulatory exposure in cosmetic and health care products, Expert in EU cosmetic regulations (EC) N° 1223/2009, US Title 21 CFR Part 700, Canada, Australia, and ASEAN Cosmetic Directive (ACD), and GCC countries. Having a very good exposure in Dossier management, Compilation of data for CTD module-1, 2, and 3, and Regulatory Submissions for various markets like the US, EU, Canada, and ASEAN markets for Health care products (OTC). I work efficiently, ensuring each task meets high-quality standards, and I'm always prepared to engage with clients regarding any work-related matters.

Expert Contract Lawyer | 24-48 Hour Turnaround I'm a licensed attorney and have drafted/reviewed 800+ legal documents in 8+ years while specializing in SaaS, technology, and commercial contracts. I've worked across India, US, UK, UAE, Canada, Australian, and Irish legal frameworks, drafting and negotiating agreements at every stage. ⸻ What I handle: - SaaS & Tech Contracts MSA/SOW structuring · SaaS & Subscription Agreements · Data Processing Agreements (GDPR/CCPA) · AI/data-use liability clauses · Software Licensing & IP frameworks - Privacy & Compliance GDPR/CCPA Privacy Policies · Terms of Service · Cookie & Consent frameworks · Cross-border data transfer risk · OneTrust-aligned data governance - Corporate & Commercial Founders' & Shareholders' Agreements · JV/Partnership Agreements · Vendor & Distributor Contracts · Employment & Contractor Agreements · Commercial Lease Agreements · Non-Disclosure Agreement - Contract Review & Negotiation Advanced redlining (Track Changes) · Liability cap structuring · Indemnity negotiation · Risk summaries · Fallback positions for faster deal closure ⸻ When clients hire me: — Closing high-value SaaS or vendor deals with enterprise clients — Preparing for Series A/B due diligence or investor scrutiny — Expanding into new jurisdictions (US, UK, UAE, Australia) — Fixing a weak or risky agreement before it's too late ⸻ Message me before you post a job - a 5-minute conversation usually clarifies exactly what you need and saves you from over-scoping (and overpaying).

▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ WHO I AM ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ I am not a consultant who reads about pharma.I have lived it — on the shop floor. 16+ years inside pharmaceutical and nutraceutical manufacturing plants across India and Singapore —as a process engineer, industrial pharmacist, and formulation specialist — before bringing that expertiseto brands worldwide on Upwork. This means when I review your formula, compliance strategy, or manufacturing plan — I am speaking from direct hands-on experience, not textbook knowledge. I help supplement and pharma brands launch FDA & GMP compliant products — without the risks, recalls, and costly reformulations that come from working with consultants who only know theory. ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ⚕️ PHARMACEUTICAL FORMULATION ★ Core Expertise ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ▸ Tablet Formulation — Standard, Fast-Dissolving, Non-Effervescent, Chewable, Coated ▸ Capsule, Gummy, Softgel & Liquid Dosage Forms ▸ Lyophilization (Freeze-Drying) Protocol Development ▸ Peptide & Sterile Product Formulation ▸ Cosmetic & Personal Care Product Development ▸ Pilot Plant to Commercial Scale-Up ▸ Master Formula Records & Batch Manufacturing Records ◆ REAL CLIENT RESULT: A supplement company needed R&D support across Ayurvedic and diabetes product lines — ongoing research, formulation, and development support. → 1,501 hours of expert execution over 2+ years → Client: "Very experienced. We look forward to a long relationship as he helps us develop and scale our business." ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 🧪 SUPPLEMENT FORMULATION ★ High Demand Specialty ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ▸ Vitamins, Minerals & Multivitamin Blends ▸ Probiotics, Prebiotics & Gut Health Formulas ▸ Sports Nutrition — Protein Powders, Pre-Workouts ▸ Herbal & Ayurvedic Supplement Development ▸ Gummy Supplement Formulation (Pectin & Gelatin) ▸ Private Label Compliance for Amazon & eRetailers ▸ Supplement Testing & Quality Specifications ◆ REAL CLIENT RESULT: A US brand needed a premium fast-dissolving tablet formulation — technically complex, non-effervescent. → Complete formulation system delivered in 10 days. → Client: "Very responsive and very good at his craft." ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 📋 REGULATORY & COMPLIANCE ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ▸ FDA, GMP, ISO, HALAL Compliance Strategy ▸ Label Compliance & Health Claims Verification ▸ IND, NDA, BLA & CTD Regulatory Submissions ▸ CMC Strategy & Documentation ▸ Import-Export Consultation — Pharma & Supplements ▸ Amazon Private Label Regulatory Compliance ▸ Multivitamin Supplement Compliance (India & Global) ◆ REAL CLIENT RESULT: A brand needed label compliance review for health claims — fast turnaround required. → Delivered same day. → Client: "Professional, knowledgeable and pragmatic." ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 🏭 MANUFACTURING & ENGINEERING ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ▸ Pharmaceutical Manufacturing Facility Consulting ▸ GMP Cleanroom Layout Design & Costing ▸ Equipment Qualification & Validation (IQ/OQ/PQ) ▸ Contract Manufacturing Connections Worldwide ▸ Offshore Pharma Manufacturing Setup Consulting ▸ Process Improvement & Troubleshooting ▸ Supplier & Manufacturer Identification ◆ REAL CLIENT RESULT: A US consultant helping a Caribbean country set upan offshore pharmaceutical manufacturing facility needed expert guidance. → 20 hours of precision consulting delivered. → 5-star review. Project completed on scope. ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 🌍 GLOBAL CLIENTS I HAVE SERVED ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ USA × Europe × Caribbean × India × Singapore Supplement Brands × Pharma Startups × Medical Clinics Research Companies × Private Label Brands × Manufacturers ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ✦ WHY CLIENTS CHOOSE ME ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ✦ 16+ years on actual shop floor — not just consulting ✦ Dr. Reddy's Lab × Alkem Lab × Singapore MNC experience ✦ Approved Chemist License — Drug Controlling Authority ✦ Upwork Enterprise client trusted — Chemistry AI Models ✦ Long-term relationships — clients scale with me ✦ "Highly recommended" — multiple independent clients ✦ Fast turnaround — even on complex technical briefs ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 🏆 MY NUMBERS ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ ✦ 100% Job Success Score ✦ Top Rated Plus — Upwork's Highest Freelancer Badge ✦ $60K+ Earned × 73 Jobs × 2,583 Hours ✦ 26 Projects Currently In Progress ✦ Clients from USA, Europe, Caribbean, India, Singapore ✦ Approved Chemist — Government Licensed ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ 📩 LET'S WORK TOGETHER ▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰▰ Tell me your product, your challenge, your market. I will tell you exactly what needs to happen — and do it. First consultation call: FREE. Response time: 0–4 hours.