Pharmaceutical Chemist and Former FDA Manager GMC, FDA Compliance and Expert WitnessRegulatoryFood and Drug Administration compliance.Prepare submissions to the Food and Drug Administration.Quality audits and implementation of changes.Simulated FDA inspection - quality and readiness audits.Establish and review quality assurance procedures for GMP and GLP.Develop and write appropriate Standard Operating Procedures (SOPs).Assist firms with Consent Decrees, Warning Letters, and 483s.Chemistry, Manufacturing, and Controls (CMC) expert.TechnicalLaboratory procedures and documentation.Pharmaceutical package and labeling and product compatibility...

Expert for Pharmaceutical Equipment Sales and DistributionFormulation process development of pharmaceuticals and nutraceutical dosage form.Tablets, capsules, injectables, creams, ointments and controlled release products.Regulatory requirements for pharmaceutical and nutraceutical including FDA, DMF, NDA, ANDA, cGMP, SOPs, auditing, labeling.Process controls including validations, operations, specifications, equipment selection, and qualifications, IQ/OQ/PQ.International liaisons/licensing of pharmaceutical and nutraceutical raw materials, finished products.Sales and marketing including setting up broker, distributor, retailer network, new...

Over 30 Years of Experience in Pharmaceutical Research and Development. Expert Support in Clinical Pharmacology, Toxicology, Drug Development, Regulatory Affairs and Clinical Research at Major Pharmaceutical CompaniesOver 30 years' experience in pharmaceutical research and development.Clinical pharmacology, toxicology, drug development, regulatory affairs and clinical research at major pharmaceutical companies.Led the research teams that discovered and developed misoprostol (Cytotec®), a worldwide anti-ulcer drugWorldwide clinical research at major pharmaceutical companies.Educator: Pharmacology and toxicology to medical, dental and p...

Pharmaceutical Technical Operations Executive Specializing in Drug Development and OperationsPharmaceutical chemistry manufacturing and control.Small virtual pharmaceutical manufacturing.Materials management and control.Pharmaceutical quality assurance.Technical services.Undisclosed Company, Managing Principal, 2010 - PresentProvide service to virtual pharmaceutical and biotechnology industry in the areas of supply chain, manufacturing, project management, quality and compliance.ProjectsLed CMC development team for a Phase I/II small molecule progr...

Executive Pharmaceutical Research Physician (MD, PhD) Consultant experienced in Clinical Research (Phase 2-4), Regulatory Affairs (inc. filings), Program Strategy Development, Medical Affairs, Advertising and Promotion, Medical Education, Life-Cycle Management and Launch Activities.Review of digital and non-digital Advertising and Promotion materials for existing brands, as well as new product launches, (U.S. and international) press releases, educational materials, sales rep training, OPDP, (Office of Prescription Drug Promotion) regulations.Life-cycle management and new product launch activities, including:Advisory boards, KOL developmen...

Pharmaceutical and Biotechnology Medical Affairs Consultant. Scientific Reviewer of promotional and advertising materials for existing brands, new products, press releases, educational materials, field training materials. Expertise in Ophthalmology, Rheumatology, Dermatology, Cardiology, and GastroenterologyStrategic Advisor and support in in multiple therapeutic areas including: Ophthalmology, Rheumatology, Dermatology, Cardiology, and Gastroenterology.Clinical and Scientific Reviewer of promotional and advertising materials for existing brands, new products, press releases, educational materials, field training materials.Scientific conte...

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...

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...

Ph.D. Pharmaceutical-Nutraceutical Formulator and Consultant for Industrial Pharma and Nutraceutical, Tablets, Capsules, Health Foods, Soft Drinks, Diary, Snacks, Nuts and Seeds, Gums in Food Products, Pectins,Nutraceutical and pharmaceutical formulation and manufacturing.Formulating hemp Cannabidiol (CBD) products.Pharmaceutical Formulation Scientist with prior industry, FDA experience in CMC writing for small molecules and biologics for both FDA and EMA.Tablet and capsule formulation, manufacturing, trade secret infringement, product labeling, and patent evaluation.Formulation and manufacturing of food, nutraceutical, and pharmaceutical...

Former FDA Investigator - Expert in Regulations, Interpretations, Medical Devices, and Dietary Supplements.Former FDA Investigator.Technical writing to build and implement quality systems.Comprehensive audit and gap analysis.CAPA and FDA responses and complaints including: Investigations, resolution, root cause analysis, corrective action plans, preventative action plans and CAPA effectiveness resolution and documentation.Employee training; laboratory and quality.Formal FDA Training in multiple program areas: Drugs; medical devices; process validation; industrial sterilization; biologics; dietary supplements; food and feed.Ability to audit...