Pharmacist skilled at retail pharmacy, complaints against pharmacist and state compliance issues for pharmacy companies.Expert on retail pharmacy operations.Pharmaceutical industry sales and promotion to doctors and retail outlets.Pharmaceutical manufacturing: Packaging and sterile filling.Retail practice of technology of a pharmacology.Knowledgeable of criminal cases involving pharmacists and prevailing law.Civil complaints involving pharmacists and pharmacies: Expert witness for both plaintiff and defense counsel.Drug selection and use including adverse effects.Trained in design and technical support of advanced coating systems for pha...

Pharmacist Specializing in Asia/ India Specific Regulatory Requirements - Marketing Authorization, Clinical Trial Permission in Biologicals and Other Market Research; Pilot Plant and Pharmaceutical AnalysisDiverse experience in pharmaceutical regulatory affairs at national and international levels.Current pharmaceutical regulations in India with major regulatory authorities.Acquired training in international forums by (WHO), World Health Organization and USFDA.Working at apex drug regulatory body in India.Inspection of clinical trials.Sourcing pharmaceutical Information.

cGMP Auditor and Expert in Chemistry Pharmaceutics (cGMP 21CFR 210,211,820, ICH Q7A), Mock Audits, GAP Analysis. Pharma and Medical Device Industries.Auditing cGMP 21CFR 210,211, cGMP 21CFR 820, and ICH Q7A.Consulting for Gap Analysis USFDA and other audits.Medical device international consulting.Conducting and organizing trainings and seminars related to Pharmaceutical and Medical device industries.Expert Witness ExperienceCompiling the U.S. norms for a warehouse located in Bhiwandi, IndiaConsulting of Pharma Company for facing USFDA Audits.

Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...

Medicinal Chemist Consultant for API Process Research, Development and API Process Start-upSynthetic organic chemist and small scale chemical process research and development.Chemical process research and development for "small molecule" drug substances.Guidance for scale-up to provide material for Phases 1 - 3 and manufacturing.Pharmaceutical facility start-up troubleshooting.Assistance with CMC section of filings.Pharmaceutical laboratory process research leading to technology transfer and scale up.Design and implementation of practical, cost-saving, processes and procedures.Experienced with 12 hands-on manufacturing start-ups of drug su...

Licensed Pharmacist Skilled with Patent Litigation and Pharmaceutical Product Development Projects, Including Regulatory IssuesExpert Witness for pharmaceutical patent litigation.Pharmaceutical reformulation and the physical-chemical characterization of new chemical entities (NCE) and APIs.X-Ray diffraction, polymorphism, solubilization, stabilization and kinetics of pharmaceutical materials.Author of regulatory (IND/NDA/CTD) CMC sections and support documents.Project planning and management for pharmaceutical development projects, including virtual contract research (CRO) companies.Pharmaceutical method development preformulation and pilo...

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...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...