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...

Consultant expert in pharmaceutical literature writing, editing and public relations.SummaryOver 35 years editing, proofreading, and writing in the environments of pharmaceutical labeling, technical publications, training, advertising, book publishing, public relations, media placement, product development, and sales. Provides editorial services on projects in the following areas:Pharmaceutical labelingCorporate internal documentsWebsite content and online publicationsTraining materialsConsumer informationIndependent Consultant, 2006 - PresentProvider of...

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...

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...

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...

FDA Regulatory Affairs and Labeling Expert for Food, Cosmetics, OTC Drugs, Pet foods, and Medical DevicesFood and Drug Administration Regulations (FDA), in foods, dietary supplements, cosmetics, OTC drugs, pet foods and medical devices.Knowledge of allowable marketing claims for FDA regulated consumer products.Research and consumer health product development.Nutrition evaluation of food products.Product formulation and marketing.Undisclosed Company, Owner and Principal, 2001 - PresentProviding clients with over 20 years' experience in b...