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New Drug Development and Approval
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to final…
Pharmaceutical Formulation, Process Development and Manufacturing of Products Focusing on Poorly Water Soluble Drugs
Extensive experience in formulation design and manufacturing process development and optimization gained working for large, medium and smaller companies.Having worked on the development of a relatively large number of small molecules at all stages of development, Expert has gained specialist…
Drug Discovery & Development, Preclinical Safety Assessment: Toxicology, Pathology & Regulatory affairs
ExpertS. Expert has over 33 years of experience in safety evaluation- Toxicology & Pathology – histopathology slides evaluation, Regulatory, drug discovery & development research, having worked in Switzerland, UK, Sweden and India. He has experience both in the pharmaceutical Industry…
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…
Pharma-BioTech Clinical Trial Development and Drug Safety, Medical Monitor
Dr. received her M.D. degree from the University of Utah School of Medicine in 1988. She then completed training to practice in remote rural communities through a program at the McKay Dee Hospital for three years as a board certified…
Drug Delivery, Formulation Development of NCE\’s, Pre-formulation, Stability, and Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral solids. For the…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
PSA Transdermal Drug Delivery & UV PSA Label Manufacturing Process & Application Development
Expert has in-depth knowledge of pressure sensitive adhesive, silicone coating material, and UV Acrylic Hot Melt adhesives. He has used his experience in PS adhesive formulating, material selection, market studies, and environmental testing to help clients determine appropriate adhesives for…