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Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
Printing, Publishing, Digital Printing, Social/Mobile Media, Marketing, Marketing Communications, Textiles & Apparel, Color, Color Management
Expert has been involved in the digital printing industry since its inception. She has held senior sales and market roles at a variety of vendors of digital printing equipment, and users of digital printing technologies. She has also written a…
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…
Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…
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…
Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials design and management, community-based research, educational programs’ development and…
Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Detergent Formulation for Laundry, Automatic Dish Wash, Multipurpose Cleaner, Cosmetics, and Personal Care
Expert has extensive experience in the development and technologies of the home care sectors in the U.S., Europe, Africa and Asia. His key trademark skills include application testing, developing protocols, procedures, creating and maintaining transparent communication channel with the customer.…
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…