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Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Sourcing / Procurement / SCM Functions
Expert is a seasoned Procurement / SCM professional with over 30 years of industry experience with a reputed diversified group of companies. He has been heading Procurement / Sourcing / SCM functions in a complex business environment for 23 years…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Pharmaceutical, Drug, Medical Device, and Management
Expert is a Pharmacist and an Attorney with a MBA and has worked in the pharmaceutical/biotech/medical device industry for 25 years.
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
pharma, regulatory, cosmetics, biosimilars
The expert is having a post-graduate degree in pharmacy which is duly recognized by the University of Toronto and is currently working as Senior Regulatory Associate at the apex drug regulatory body in India i.e CDSCO. He is responsible for…
Transportation, Safety, Driver Training, Driver Behavior, Business Financial & Accident Investigation
Expert provides very strong subject matter in the following: ▪ command in motor carrier industry practices and regulatory compliance ▪ truck-related accidents ▪ transportation economics ▪ warehousing and distribution management ▪ independent contractor and broker operations ▪ hazardous materials transportation…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Sterile Compounding, USP 797/795/800, Home Infusion, TJC/ACHC/BOP Regulations, Healthcare/Change/Project Management, Acute/Hospital Pharmacy Management, Pharmacy Automation, Mail Order Pharmacy, DME
Expert is an experienced PharmD, Director of Pharmacy and Assistant Clinical Professor with 6 years of experience at small, medium, large, level 1 trauma academic, acute care and long-term acute care hospitals. She has deep experience in pharmacy operations, finance,…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…