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...

Experience in domestic & international pharmaceutical research, development and general management of ethical & OTC pharmaceutical products and technologyThirty years of experience in domestic & international pharmaceutical research, development and general management of a broad range of ethical and OTC parmaceutical products and technology.Strong goal orientation, effective communication skills, proven track record, and bottom-line accountability.Significant contributions to business-wide strategic goal setting, improvement processes, outsourcing, and vendor selection.

Pharmaceutical Consultant for Process Research and Development Including Production of Controlled Substances, API, Platinum and Terpene Chemistry and Asymmetric Synthesis.Pharmaceutical process research and development.Development of active pharmaceutical ingredients (API).Organic synthesis, including platinum chemistry, synthesis of controlled substances, cannabinoid, opioid and heterocyclic chemistry.Terpene chemistry, amino acid, carbohydrate chemistry, organometallic chemistry and asymmetric synthesis.Good manufacturing practice (GMP) for pharmaceuticals.Seventeen years of pharmaceutical process research and development.Research experi...

Dosage From Pharmaceutical Consultant: Facilities Management and GMP ComplianceFormulation and process development of multiple types of pharmaceutical dosage forms.Research and development, optimization, manufacturing and packaging of solid, liquid and powdered dosage forms.Scale up and technology transfer of multiple dosage forms.Equipment and processing knowledge, product processing/equipment trouble-shooting and facility validation and qualification activities.Identifying and implementing significant operational cost savings in pharmaceutical operations.Auditing of diverse cGXP operations (API manufacture, laboratory operations, clinica...

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...

Borosilicate Pharmaceutical (Type I Glass Containers), Syringe Formats, Vials, Cartridges, Ampules, Injectors and Injector Systems ConsultantBorosilicate pharmaceutical (technical support for Type I glass containers Borosilicate glass-neutral glass) expert for parenteral packaging as well as barrier film expertise for the packaging of sensitive solid dose drugs.Inorganic glass material for pharmaceutical sectors (mostly silicates) or mixture of materials when heated up then cooled, solidifying without crystallization.Technical review of Type I glass suitable for packaging material in most preparations whether parenteral or non-parenteral,...

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...

Consumer Product and Pharmaceutical Market Research Consultant, Specializing in Quantitative and Qualitative Marketing Research Among Consumers and Health Care Professionals.Concept/Positioning: Insight, benefits, RTB (Reason To Believe) optimization and claim sorts.Product: In home use, controlled store tests, test market pricing, color and taste tests.Communication: Copy testing, packaging, eye tracking and name tests.Category and market: Market segmentation and market structure.Tracking: Awareness and usage, advertising and equity.Panel: Syndicated and custom diaries.Multicultural: Hispanic custom and syndicated studies and retail p...

An analytical chemist with extensive experience in analysis of elastomer formulations, plastic & medical packaging plus controlled environmental agricultural research. Experience in Ukraine/Uganda.Summary Over 45 years of experience as an analytical chemist in the rubber, plastics, and pharmaceutical industry (30 years) and as a technical consultant (15 years).   Knowledgeable in the major analytical chemistry methods – chromatography, spectroscopy, and wet chemistry.  International experience in Germany, Ukraine, and Uganda.  Effective problem solver with the ability to apply technical expertise and solutions to...

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...