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Lyophilization
Expert's career in the pharmaceutical industry spans over 20 years. His work has focused on the following: • Supervision of pharmaceutical plants and technological transfers. • Development and implementation of operational standard procedures related to manufacturing processes and quality control.…
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…
Pharmaceuticals, Drug Delivery, OTC, and Rx products
Expert actively consults in nearly all routes of drug delivery, including oral, transdermal, topical, inhalation, injection/infusion, nasal, buccal and others. He holds a Ph.D in Polymer Science and Engineering, as well as an MS on the same topic. He holds…
Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions
Expert is a consultant to the US FDA for Quality issues associated with the manufacture of pharmaceuticals. Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Pharmaceutical Marketing, Sales, Portfolio Management, and Life-cycle Managment
Expert has over 30 years' experience in the pharmaceutical industry ranging from pharmaceutical marketing, sales, product portfolio management, life-cycle management, commercial viability of new and existing drugs, OTC drug experience and patent litigation experience in Federal, and District courts both…
Industrial Piping Design and Construction
As a consultant, Expert can lend experience-backed technical assistance in cost-effective installations of process piping system assemblies, either by verifying compliance with a design package or by modifying a design package as required to ease constructability and control costs. Expert…
Digital, e-commerce, Publishing nPlatforms, Insurance, FinTech, Software Development, and IT Strategy
Expert is an acknowledged digital and software development professional with wide technical, commercial, industry and territorial knowledge and experience, most notably in online product development and digital transformation. For 20+ years, he has been helping businesses grow through technical insight,…
Pharmaceutical Marketing, Branding
Expert is a Full Professor in the Department of Marketing at in Montreal. Prior to joining, she obtained significant marketing management experience in the pharmaceutical industry and held various positions in market research, sales, product management, strategic planning, and licensing…