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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…
Pharmaceutical Dosage Forms
Expert is the founder and the President and Founder of a pharmaceutical technology company since 1997, and Adjunct Professor of Pharmaceutical Sciences, Faculty of Pharmacy, since 2019. Prior to that he was as a faculty member at the Faculty of…
HPAPIs, Pharmaceutical
Imaginative and resourceful professional with multi-faceted leadership experience in project/program management and drug development and manufacturing. Possesses key business skill sets including: strategy planning and execution, new product development, negotiation and influencing, and continuous process improvement. Strong technical skills to…
Formulation Science, Formulation Chemistry
Expert is an experienced ‘Formulation Scientist’ offering outstanding Product Development skills for Oral Liquids, OTC Products, Hand Sanitizers, Personal Care Products, Topicals Products, Tablets, Parenteral Products. Expert can also help in modifying existing formula, offer expert guidance on product design,…
Formulation
Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance. Proven track record of 30 years in effective product development…
Pharmaceutical Formulation
Expert received his M.S. and doctorate in Pharmaceutical science from Long Island University, Brooklyn campus in 2017. During his doctoral dissertation, he worked on the rheological characterization of transdermal formulation and application of rheological models in product development and scale-up…
Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…
GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Rapid Development of Controlled Release Drug and Drug-Device Combination Products
Expert, Ph.D., is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, with special focus on drug delivery platforms and drug-device…