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Pharmacokinetics/Pharmacodynamics
Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a…
Biomaterials, Biotechnology, Medical Devices, Polymer Chemistry, Biomedical Engineering, Materials Engineering, Healthcare (regulatory), Intellectual Property Strategy
Expert has more than 20 years experience in biomaterials and medical devices, both in industry and as a university professor performing research. His research has a translational focus, so he has conducted numerous pivotal animal studies related to the fields…
Medical Devices, Business Development, Regulatory Affairs, Project Management
Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
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…
New Ingredient Product Development, Regulatory/ Compliance, OSHA/EHS, Thermal/ Non-Thermal Processing
Experienced Food Science Technical Professional with a track record of improving results in varied food manufacturing environments. Highly motivated team builder/player. Able to provide clear, strategic direction on Food Safety issues. Well-versed in Quality Assurance, Regulatory Affairs, Purchasing, Food Safety…
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,…
Organic Chemistry, Biocatalysis, Fermentation, Industrial Biotechnology, Chemical Process Development, Patent Liaison, Expert Witness for Patent Litigation
Expert has over 30 years of experience leading process development groups in a variety of fields. He employs biocatalysis and other biological methods to perform organic synthesis. In his current role, Expert offers executive-level technical strategy, project management, and due…
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…