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Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China
Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up a cGMP manufacturing…
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…
Controlled Release, Microencapsulation, Drug delivery, Taste Masking, Bioavailability Enhancement
Expert has almost twenty years of experience in the formulation of pharmaceuticals for controlled release delivery. This work includes drug bioavailability enhancement, tastemasking, enteric protection, tableting, colonic delivery, prevention of ingredient interaction, nasal delivery, and buccal delivery. He has employed…
Biodegradable Systems for Controlled-Release Drug Delivery
Expert has a D.Sc. in bioorganic chemistry, a Ph.D. in polymer chemistry and over 25 years of experience in analytical and physical chemistry of biopolymers. In a very recent assignment Expert has established and directed an analytical chemistry department with…
Industrial Chemistry Expert: R&D of Materials, Coating, Adhesive, & Sealant Applications
Expert has 20 years of experience in Industrial Chemistry, including experience in emulsion development, coating, adhesive, sealant, paint, textile, leather, solvent cement, rubber adhesive, styrene acrylic, pure acrylic, VAM_VEOVA, hybrid, core shell, and opaque polymer. He holds a PhD, Masters…
Green and Clean Energy: Petrochemical, Refining, and Downstream Chemical and Utilities Sectors: Pre-commissioning, Commissioning, and Plant Startup
Executive summary: Expert has 17 years' experience in the petrochemical, refining, and downstream chemical and utilities sector. His experience includes pre-commissioning, commissioning, plant routine startup, shutdown, and emergency operations. His management roles include service as process trainer and process commissioning…
Sustainability Advisory Services, Sustainability Strategic Planning, Sustainability Programs
She provided strategic direction and planning for design and delivery of stakeholder engagement workshop, Collaborating on Standards Solutions: Sustainable Buildings in Canada, for a broad cross-section of the building and related industry sectors and organizations to support market transformation for…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Litigation (with 30+ Years of Experience Presenting in Court and Writing Reports)
For more than 30 years, Expert has represented clients in multiple interrelated areas: complex commercial litigation and dispute resolution; litigation involving fiduciaries, wills and trusts; labor and employment law; market channel matters involving dealers, distributors, and sales representatives; and the…
Equipment Validation
Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE Ackley Imprinter Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves. Korsch - XL400WIP,…