Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Consultant with Diverse Pharmaceutical Experience in Formulation Development, Manufacturing, Technology and Site Transfer, Process Design, Scale-Up, and ValidationPharmaceutical formulation development, manufacturing technology transfer, site transfer, process design optimization, and scale-up for domestic and international clients.Product development using QbD approach, process scale-up and optimization, process validation.Drive technology platforms such as solid and Liquid orals, aseptic filling, softgels, orally disintegrating granules, powders, MR products, X-ray contrast media, peptide injectable product, topicals, steroids and hormo...

Pharmaceutical: Drug Development and Deliverables, Project Management, Global Clinical Researcher, Medical Writing in Various Platforms, Provide Drug Product Reviews and Statistics ConsultingPharmaceutical development and deliverables: Print modules, slide decks, annotated prescribing information, storyboards for digital media for use in the training of sales force and medical science liaisons. Medical literature identification and interpretation, clinical studies, therapeutic guidelines, prescribing Information, and market research. Drug products evaluation, drug statics and author of technical medical reports. Project proposals and...

Extensive experience in toxicology, pharmacology, product safety, and regulatory standards.Consulting in toxicology and product safety evaluation and assessment to the following industries: OTC drugs, pharmaceuticals, cosmetics, personal care products, chemical household products, medical devices and biotechnology.Establish and manage product safety compliance, regulatory standards and approvals.Design and manage safety evaluation and toxicology research programs that meet industry standards and are successful in achieving regulatory approval.Consultation and scientific support for product liability and toxic injury.California Proposition...