Hire the Best Biotechnology Regulatory Affairs Professionals

I am a biomedical researcher and scientific consultant with 7+ years of experience in infectious diseases, public health and biology. I have contributed to international projects, including collaborations with the Centers for Disease Control and Prevention (CDC), and specialize in scientific writing, research support, and data analysis (R). I can support you with: - Scientific writing and editing - Literature reviews - Data analysis - Public health documentation - Improving your understanding in biology matters (teacher) Reliable, detail-oriented, and committed to delivering high-quality work on time.

I help supplement brands take early concepts, existing formulas and manufacturing problems and turn them into products that are scientifically sound, commercially realistic and suitable for their intended market. I’m a biochemist with an MSc and studied at Wageningen University & Research in the Netherlands. My background combines biochemistry, chemistry, food science and more than 15 years of practical formulation and manufacturing experience. That scientific background affects how I approach formulation. I don’t only check whether an ingredient is popular or whether it fits on a label. I look at its mechanism, human evidence, effective dose, source material, standardization, bioavailability, safety, interactions and behaviour inside the finished dosage form. Most clients come to me with one of three things: an early product idea, a formula they are not completely confident in, or a manufacturer telling them the product needs to be changed before it can be produced. I can help with: * New supplement formulation and reformulation * Biochemical and clinical review of existing formulas * Health Canada NPN applications, amendments and reviewer responses * US FDA ingredient, claim, Supplement Facts and label reviews * Australian TGA formula, ingredient, dose, indication and evidence reviews * International formula screening for the EU/EEA, UK, India and Asian markets * Manufacturer-ready specifications and Bills of Materials * Ingredient standardization, potency, overage and yield calculations * Stability, preservation, solubility, flavour and texture problems * CMO screening, technical transfer and pilot-production support * Independent audits of manufacturer proposals, formulas and cost models I have worked on approximately 50 Health Canada NPN applications across Class I, II and III. This includes preparing applications, Finished Product Specifications, label text, evidence packages, amendments and responses to Health Canada questions. I also support products intended for the US dietary supplement market and Australian complementary medicine market. The FDA, Health Canada and TGA systems are not interchangeable. Australia generally treats supplements much more like medicines, with tighter controls around permitted ingredients, therapeutic indications, evidence, manufacturing and product listings. A formula that works in the US may not work in Canada, Australia, Europe or India without changes. I compare ingredient status, dose limits, claims, warnings, evidence and manufacturing requirements early so clients do not develop a product that later needs to be reformulated. For markets requiring a local sponsor, authorized representative or country-specific legal filing, I prepare the scientific and technical package and work alongside the appropriate local regulatory specialist. My biochemistry work can include: * Clinical literature and ingredient evidence reviews * Mechanism-of-action and biological pathway analysis * Safety, contraindication and interaction assessments * Extract-ratio, standardization and active-yield calculations * Bioavailability and pharmacokinetic reviews * Claim substantiation and evidence-gap analysis * Comparison of branded ingredients and delivery technologies I formulate capsules, tablets, powders, gummies, stick packs, oral pouches, functional beverages, liquid supplements and selected pet products. Each formula is built around the intended customer, market, dosage form, clinical evidence, regulatory pathway, cost target and what the manufacturer can realistically produce. When it provides a genuine advantage, I can also work with delivery technologies such as liposomal systems, emulsions, cyclodextrin complexes, phytosomes and microencapsulation. I do not add expensive technology simply because it sounds good in marketing. It needs to improve stability, absorption, taste or manufacturability. I also consult within Canadian cGMP manufacturing, so I understand what happens after a formula leaves the spreadsheet. I can identify problems involving raw-material sourcing, bulk density, powder flow, gummy payload, flavour masking, preservation, water activity, packaging and equipment limitations before they become expensive production problems. Depending on the project, my deliverables can include: * A manufacturer-ready formula and specification sheet * Ingredient and dosing rationale with supporting references * Regulatory, safety, stability, sensory and cost risk flags * Proposed claims, directions and required cautions * Finished Product Specifications and NPN supporting documents * Manufacturing instructions and pilot-run recommendations * CMO qualification and comparison documents * Support communicating with manufacturers, laboratories and suppliers I am fairly direct about what works and what does not. If a formula is underdosed, unnecessarily complicated, difficult to manufacture or unlikely to support its intended claims, I will explain the problem and give you

I’m Dr. Abhijath - a Top Rated Plus Freelancer with $100K+ earned on Upwork, 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 help companies navigate international regulatory compliance for food, dietary supplements, cosmetics, chemicals, and consumer products entering the US, Canadian, EU, and UK markets. ⭐ Top Rated on Upwork | 5-Star Client Feedback 🌎 500+ clients and brands supported internationally I work with startups, established brands, manufacturers, and importers to identify applicable regulatory requirements and provide practical, product-specific compliance support. 🍽️ FOOD & DIETARY SUPPLEMENTS • FDA Food Facility Registration & US Agent services • FSVP (Foreign Supplier Verification Program) • FDA Prior Notice & import compliance • Food & supplement labeling for U.S., Canada, EU & UK • Nutrition Facts, Supplement Facts, Canadian Nutrition Facts Table & EU/UK nutrition declaration review • Ingredient, formulation, allergen & claims assessment • FSMA compliance support • PCQI - Human and Animal Food 💄 COSMETICS • US. FDA cosmetic & MoCRA compliance • FDA facility registration & cosmetic product listing • Health Canada Cosmetic Notification Form (CNF) • EU CPNP & UK SCPN cosmetic notifications • Cosmetic labeling, ingredient & claims review • OTC vs. cosmetic classification assessment • CPSR compliance support • EU/UK Responsible Person requirements 🧪 CHEMICALS & CONSUMER PRODUCTS • Safety Data Sheets (SDS), OSHA & GHS compliance • Cleaning & household product compliance • California Proposition 65 (Prop 65) • U.S. & Canadian consumer product safety assessments (CPSC / CCPSA) • GCC/CPC requirements & CPSC eFiling • CE/UKCA applicability assessments • Product labeling, warnings & testing requirements FDA IMPORT DETENTIONS & ENFORCEMENT • FDA detained shipment release support • Form FDA 766 – relabeling/reconditioning applications • Corrective actions for misbranding and other compliance violations • FDA detention responses, evidence & regulatory submissions • Import Alert / DWPE removal petitions • Support with FDA communications and import compliance issues 🌎 INTERNATIONAL COMPLIANCE I support regulatory projects across the United States, Canada, European Union, and United Kingdom, including product classification, labeling, registrations and notifications, import requirements, Responsible Person/Authorized Representative requirements, CE/UKCA, WEEE/EPR, and market-entry compliance. My goal is simple: determine what applies to your product, what does not, and what needs to be done before you enter the market, helping you export with confidence while reducing the risk of detentions, penalties, compliance issues, and costly delays. If you are launching, importing, or selling a regulated product, send me your product details, target market, and what you need help with. *Regulatory services are based on the information provided, do not constitute legal advice, and do not guarantee regulatory approval.

I help companies turn product ideas into products that can actually be manufactured, exported, certified and placed on the market. My background combines formulation, product development, regulatory affairs, quality systems and international compliance across food, supplements, cosmetics and consumer products. Over the last decade, I have worked at the intersection of R&D, regulatory, quality, manufacturing and supply chain functions, which means I am often brought in when a project is technically feasible but the path to market is unclear. I have supported product development, ingredient and supplier qualification, technical documentation, claims and label reviews, certification projects, quality systems, international market access and compliance activities across Europe, the UK, the United States, Canada and Asia. My experience also includes working with manufacturers, certification bodies, auditors, import/export requirements and cross-border regulatory frameworks where commercial, technical and compliance considerations must align. What clients usually value is not only regulatory knowledge, but the ability to identify risks early, challenge assumptions and find practical solutions before time and money are invested in the wrong direction. Whether the project involves formulation, market access, supplier documentation, certification readiness, compliance reviews or international expansion, my focus is always the same: helping companies make informed decisions based on science, regulations and business reality.

I am fulltime freelancer. Education: M.S. (Pharmacology and Toxicology), 2011 In last 7 years, I acquired multiple skill sets by working in different areas of Healthcare/medical. • Pharmaceutical R&D • Consumer (Cosmetic) Safety Healthcare Regulatory for EU and Latin America market: • Health Economics and Outcome Research: 3 months • Ad-hoc literature search projects on Upwork and fiverr I may not have exact skillset for your project. However, I assure you that I can work efficiently due to diverse experience in medical sector. I am always available for trial work without any charge.