Abhijath M.

Regulatory Affairs Consultant (RAPS) USFDA & EMA | Formulation Advisor

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