Hire the Best Phalcon Specialists
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)

ESD Consultant with 4+ years' experience in BERS, HERO, and THERM, specialising in BASIX, Section 3.12, and Section J compliance. Well-versed in NCC 2019 & 2022, delivering accurate, code-compliant, and sustainable design solutions.

I possess a Master’s Degree in Computer Software Engineering, I bring forth over 10 years of immersive experience in the dynamic realms of web design and development. My journey has traversed diverse industries, where I've seamlessly blended innovation with functionality for businesses ranging from petite enterprises to medium-sized entities and large corporations. My toolkit includes the mastery of PHP, WordPress, Webflow, Laravel, HTML5, CSS, Bootstrap, jQuery, and the fine art of SEO. Whether you're a burgeoning startup, a well-established business, or in pursuit of an MVP, rest assured you'll receive top-notch services at a cost that won't break the bank. ✦My primary expertise encompasses: • PHP / MySQL • HTML5, CSS3, JavaScript • MEAN and MERN stack (MongoDB, Express, NodeJS, React/Angular) • CMS Development (WordPress, Webflow, Shopify) • Framework (CodeIgniter, YII, Laravel, Phalcon, CakePHP) • Responsive design (Bootstrap, Foundation Zurb) • Seamless payment gateway integration (Stripe, Paypal, Braintree, etc.) • Quality services tailored to your needs are guaranteed. ✦Engaging with Me: Accessible Around the Clock: Find a time that suits you best – no need to rearrange your busy life or work schedule. Your Preferred Communication: Choose how we connect; whether by email, phone, or Skype – whatever suits your preference! With over a decade of experience in designing and developing websites and web applications, I possess a profound understanding of how technology can seamlessly align with both business requirements and customer needs. My passion lies in working on websites, a commitment I've upheld every single day for the past 10+ years. I operate with speed, efficiency, and a meticulous eye for detail, always online and ready to contribute. I'm eager to assist with any web development, customization, or maintenance tasks and am happy to address any questions you may have. Building lasting relationships with clients is a priority for me, making long-term projects my primary focus. I eagerly await the opportunity to connect with you! Best regards, Nayana

I am a Mechanical Engineer with over 36 years of international experience in EPC, Construction, Quality, Health, Safety, Environment (QHSE), and Project Management across Oil & Gas, Petrochemical, Fertilizer, LNG, Power, Manufacturing, Infrastructure, and Industrial projects. I help organizations develop, implement, and improve Quality, Health, Safety, Environmental, and Risk Management systems while delivering professional engineering and technical documentation that complies with international standards, regulatory requirements, and industry best practices. My expertise combines extensive field experience with practical documentation development, ensuring that every deliverable is technically sound, auditable, implementation-focused, and client-ready. SERVICES OFFERED PROCESS SAFETY & RISK MANAGEMENT • Process Hazard Analysis (PHA) • HAZOP Studies • Risk Assessments • Job Safety Analysis (JSA) • Construction Risk Assessments • Environmental Risk Assessments • Permit-to-Work Procedures • Safety Procedures and Work Instructions • Emergency Response Plans • Environmental Emergency Response Plans • Verification Requirements Traceability Matrix (VRTM) • Safety Management Systems QHSE & ISO MANAGEMENT SYSTEMS • ISO 9001 Quality Management System Documentation • ISO 14001 Environmental Management System Documentation • ISO 45001 Occupational Health & Safety Documentation • Integrated Management Systems (IMS) • QHSE Manuals • Policies and Procedures • Compliance Registers • Risk and Opportunity Registers • Internal Audit Documentation • Contractor Management Procedures TECHNICAL DOCUMENTATION & ENGINEERING WRITING • Standard Operating Procedures (SOP) • Method Statements • Inspection and Test Plans (ITP) • Quality Management Plans • HSE Plans • Environmental Management Plans • Construction Environmental Management Plans (CEMP) • Waste Management Plans • Traffic Management Plans • Technical Reports • Engineering Specifications • Work Instructions • Training Manuals • Operational Manuals WHY WORK WITH ME? ✔ 36+ years of international EPC, Construction, and Industrial Project experience ✔ Extensive experience across Oil & Gas, LNG, Petrochemical, Fertilizer, Power, Manufacturing, and Infrastructure sectors ✔ Practical field knowledge combined with professional documentation expertise ✔ Strong understanding of ISO Standards, QHSE Systems, Risk Management, and Regulatory Compliance ✔ Client-focused approach with attention to quality, accuracy, and timely delivery My objective is to provide clear, professional, and implementation-focused documentation that supports operational excellence, project success, regulatory compliance, and continual improvement. If you require ISO documentation, risk assessments, QHSE systems, SOPs, technical manuals, engineering procedures, or environmental management documentation, I would be pleased to support your project.

I am a creative and optimistic Chemical Engineer with 5 years of experience as a Process Design Engineer working as full time freelancr. I'm a Certified Aspen user from NPTEL. I'm a Certified Process Safety Engineer and ISRS Assessor. I have extensive experience with: * Process simulation (Aspen Hysys ,Aspen Plus, Chemcad) *Process Flow Diagram(PFD) ,PI &D development *Material and heat balance sheet preparation on Excel * Process Optimization *Energy Efficiency Optimization (HEN ) *PFD making on VISIO *Piping and Instrumentation Diagram (P&ID) formation *Equipment Sizing *Hydraulic Calculations *Risk assessment in chemical and biochemical systems *Cause & Effect diagrams development *Electrolysis process R and D work * Pilot plant scale up *AutoCad I have experience as an instructor: * Preparing projects related chemical engineering course work * Preparation for course outlines and exams

Sourcing Specialist and Project Management professional with more than 12 years of experience in projects, operations, sourcing, product development and quality control. I've helped many companies in setting up their manufacturing base in India. Sourced and inspected (as TPI) pipes & tubes (SMLS/ERW), bends, fittings, flanges, steel products, wires rods, precision machining products, glass jars/bottles for cosmetics packaging, tiles, fabrics/textiles, PPE, artisan products, cutlery, Incense Sticks, Tiles and home decor products. Managed supplier research, vendor development, factory audits, production expediting, quality control inspections and shipping coordination. As an Engineering professional, involved in Fitness for Service, Remaining Life Assessment, Corrosion Growth Assessment, Risk & Reliability Management, Risk Based Inspection, HAZOP, Quantitative/Qualitative Risk Assessment and Surge Analysis studies. Conducted various training program on asset integrity management to Institutional and industrial organizations. Supply Chain Management Services: a. Supplier / Manufacturer Research b. Vendor Development c. Factory Audits d. Production Expediting e. Unannounced Audits and Inspections f. Quality Control and Pre-shipment QC Inspections g. Logistics and Shipping Coordination h. Capability Assessment and Comparative Insights on Digital Transformation Tools such as Ivalua, Coupa, SAP Ariba, S/4 HANA, Jagger, Zycus etc. i. Supply Chain Management Consulting. j. SAP Ariba and S/4 Hana Integration. k. Consulting on contract formation, contract management, legal terms and conditions review etc. l. Consulting on Company Law. m. Consulting on Vendor Management System (VMS) and Warehouse Management System (WMS). Excellent communications and networking skills with an extended freelance expert team to provide variety of solutions. Thank you visiting my profile. Looking forward to discussing about your project.