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Cosmetics, Packaged OTC Drugs, Nutraceuticals, Design, Processing, Quality Issues
Expert has fifty years of actual bench experience doing laboratory and pilot development of the listed areas of expertise. Expert has visited the FDA over 100 times in support of various submissions. Expert has worked for several contract manufactures of…
Personal Care and OTC Products; New and Existing Product Formulation and Development
Expert has been involved in formulating a variety of cosmetics, personal care and OTC products. She works with formulation and manufacturing development of skin care, anti-wrinkle (Elastiderm Decolletage Wrinkle Reducing Lotion), eye area (Elastiderm Eye Treatment Cream), anti-rosacea (Hydrating Complexion…
Pharmaceutical Product Development, Analytical Chemistry, Material Science, Process Development
Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated $1B/year annual revenue drug/device product. Expert is…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument department at Altus Pharmaceuticals…
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…
Designing and Implementing Quality Control Stability Programs, Authoring Stability Sections
Expert has over 10 years experience in the areas of QC Stability (Drug Product and API). In addition, Expert has many years of experience in drafting QC Stability sections for the following submissions for the FDA: IND, NDA, BLA, PAS,…
Medical & Nursing, Alternative and Holistic Medicine
Expert M.D. (A.M.), one of the most sort-after Doctors of his region, is a graduate (Bachelor of Ayurvedic Medicine and Surgery) from India’s oldest Ayurvedic Institute- Dayanand Ayurvedic College, Jalandhar (Pb.). He is the Director of *BR. Herbals Ayurvedic Hospital,…
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…
Pharmaceutical Development, strategy planning and execution
Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher…