Hire the Best Regulatory Compliance Freelancers
in India

I’m Dr. Abhijath - a Top Rated Plus Freelancer with 10+ years of experience, helping pharma, biotech, medical device, and dietary supplement companies with Regulatory Affairs, FDA submissions, product formulation, and clinical/medical documentation. I specialise in Regulatory Affairs for Drugs & Medical Devices and also work as a Drug & Dietary Supplement Formulation Expert. I’m a Pharm.D with a postgraduate qualification in Regulatory Affairs and currently work as a Regulatory Lead (Contract) on U.S.-focused programs. If you’re developing a pharmaceutical, biotech, nutraceutical, dietary supplement, or medical device product, I can help you turn the science behind it into a clear, compliant, submission-ready and market-ready package. My experience across Regulatory Affairs, Clinical Research, Medical Affairs, Pharmacovigilance, and formulation science allows me to look beyond just one document. I understand how the product, clinical evidence, formulation, claims, labeling, regulatory strategy, and submission documentation need to work together. Clients typically hire me for: • U.S. FDA regulatory strategy and submission support • IND, NDA, ANDA and CTD/eCTD documentation • Pre-IND preparation and FDA correspondence • Regulatory, clinical, CMC and medical writing • Labelling of Drugs, Devices, Nutraceuticals • Protocol, Investigator’s Brochure and Informed Consent Form review • Dietary Supplement & Nutraceutical Formulation - U.S., EU & India • Ingredient selection, scientific rationale and formulation optimization • Supplement claims, labeling and technical documentation • Medical Device 510(k) regulatory support • EU MDR & IVDR documentation • Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) • Medical Device technical documentation and regulatory gap assessment • Clinical research, ethics and IRB submission support I focus on understanding what you are trying to develop, where you want to market it, what regulators will expect, and what needs to be done to get there. You’ll get clear communication, practical recommendations, scientifically defensible documentation, and work developed with regulatory review in mind - not simply documents created to complete a checklist. Whether you are preparing an FDA or EMA submission, developing a new supplement formulation, starting a clinical program, or bringing a medical device to market, I can support you from strategy through execution. Have a regulatory or product development challenge? Send me a message and let’s discuss the best way to move your project forward. Areas of Expertise : Regulatory Affairs | FDA Compliance | FDA Regulatory Consulting | IND | NDA | ANDA | 505(b)(2) | CTD | eCTD | CMC | Regulatory Writing | Medical Writing | Clinical Research | Clinical Trial | Protocol Development | Investigator’s Brochure | Dietary Supplements | Nutraceutical Formulation | Product Formulation | Supplement Formulation | FDA Labeling | Regulatory Compliance | Medical Devices | 510(k) | EU MDR | IVDR | Clinical Evaluation Report | Performance Evaluation Report | Technical Documentation | Pharmacovigilance

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.

An experienced Amazon Compliance and Catalog Manager specializing in comprehensive seller account management across EU, UK, and USA marketplaces. Skilled in account health management, listing optimization, catalog management, inventory coordination, and regulatory compliance, with a structured and detail-oriented approach to resolving complex marketplace issues. Core competencies include Amazon Seller Central, bulk compliance management, complex catalog operations, accurate product data uploads, Variation creation via feed file, and marketplace policy adherence. Proven ability to manage high-volume catalog and compliance tasks while maintaining accuracy, consistency, and operational efficiency across multiple Amazon marketplaces. While Amazon remains my primary focus, from Brand Registry and Storefront setup to complex troubleshooting, I also help brands expand seamlessly across Walmart, Shopify, eBay, Etsy, and Temu for maximum market reach. My work is focused on solving high-stakes problems, optimizing backend systems, and scaling multi-channel sales. 📈 Recent Work Highlights: * Handled 200+ successful projects across USA, UK, EU, and AU marketplaces * Successfully resolved thousands of complex listing, compliance, and catalog issues * Improved an Amazon Account Health Rating from 220 → 284 * Resolved 6,500+ GPSR compliance violations across global marketplaces * Managed 2,500+ ASINs for compliance and account-related issues * Resolved 3,000+ complex listing & parent-child variation issues * Created 104 variations from a single feed upload with zero errors * Managed 6,100+ child products across 250+ FBA and FBM conditions 🚀 What I Help With: 🔴 Amazon Core Expertise & Account Health * Brand Setup & Expansion: Brand Registry, Storefront setup, A+ Content, and Growth Strategy * Compliance & Suspension Fixes: Section 3 reinstatement, POA drafting, policy violations, and listing recovery * Global Compliance: EU/UK GPSR, EPR, WEEE, VAT, and Product Safety requirements * Advanced Cataloging: Flat file bulk uploads, complex variations, browse node fixes, and listing unsuppression * New Product Listings: Accurate product listings with SEO-optimized content as per Amazon guidelines 🌍 Multi-Marketplace Expansion & Multi-Channel E-Commerce * Walmart & eBay: Account setup, bulk catalog feed uploads, inventory sync, and account health monitoring * Shopify: Store setup, product catalog migration, multi-channel app integration, and fulfillment management * Etsy & Temu: Niche marketplace onboarding, store configuration, and compliance setup * Global Expansion: UK to EU expansion (DE, FR, IT, ES, NL, SE, PL, BE), USA, AU, NARF, and BIL setup ⚙️ Operations, FBA & Logistics * FBA shipment creation, labeling, and inbound issue resolution * Stranded inventory recovery and multi-channel inventory routing * Case escalations with seller support teams across platforms 💡 Why Clients Work With Me: ✔ 7+ Years of Hands-on Experience: Proven track record with 200+ completed projects in US, UK, EU, and AU markets ✔ Multi-Channel Scalability: Deep experience across Amazon, Shopify, Walmart, eBay, Etsy, and Temu ✔ Structured Problem Solving: Root-cause investigation instead of temporary Band-Aid fixes ✔ Direct & Fast Execution: Clear communication with zero fluff Available for one-time emergency fixes, account audits, catalog setup, or long-term multi-channel management. 📩 Got a blocked listing, compliance error, or scaling bottleneck? Send me a quick message with your issue, and I will outline a clear step-by-step plan to fix it.

I'm Alokita Krishna, a Business & Product Strategy Consultant specializing in market research, product strategy, regulatory compliance, operations, and business development. Over the years, I’ve partnered with startups, SMEs, and enterprise teams to streamline operations, strengthen governance frameworks, support market expansion, and manage cross-functional initiatives across multiple jurisdictions. My core services include: • Product Operations – Translating business, legal, and technical requirements into actionable operational workflows – Driving cross-functional alignment between product, compliance, legal, operations, and leadership teams – Structuring market entry and operational readiness strategies for new products and jurisdictions – Supporting accreditation, audit readiness, and regulatory preparation initiatives • Compliance & Governance – Developing and implementing practical compliance programs tailored to business operations – Conducting regulatory research and providing advisory support across regulated industries and global markets – Designing internal control frameworks, governance structures, and risk management processes – Supporting cross-border compliance strategy, policy development, and operational governance initiatives • Operations & Strategy – Designing scalable operating models and improving operational efficiency across teams and functions – Creating SOPs, process documentation, workflows, and internal knowledge systems – Providing fractional operations and strategic leadership support for growing organizations – Assisting with roadmap planning, prioritization, execution tracking, and process optimization • Bids, Proposals & RFPs – Writing and managing federal, state, and commercial RFP responses and proposal submissions – Developing proposal strategies, response structures, compliance matrices, and submission workflows – Supporting bid pipeline management, opportunity evaluation, and capture planning – Assisting organizations with government contracting preparation, documentation, and operational readiness I bring a combination of strategic thinking, operational discipline, and regulatory expertise to every engagement. Whether you need help setting up internal systems, preparing winning proposals, navigating regulatory environments, or scaling operations efficiently, I focus on delivering practical, execution-oriented solutions tailored to your business goals. If you’re looking for a dependable strategic partner who can operate across legal, operational, and compliance functions with clarity and precision, I’d be glad to collaborate.