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Bionanosciences, Nanomaterial interfacing & targeting, Cell biology & biophysics, Molecular imaging, Microscopy
The expert has been actively designing and developing surface chemistries and coatings that allow a controlled organic/inorganic interfacing of colloidal nanomaterials with biomolecules. Over the past 14 years, projects carried out by the expert have focused on engineering the surface…
Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products
Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups…
Product Development, Quality Assurance, GMP Audits, Qualifications, Troubleshooting, Pharmaceutical, Nutraceutical, Production Issues, GMP Compliance, Pharmaceutical Dosage Forms, Quality Control
Expert has more than 24 years of experience Internationally (New Zealand; Australia; Oman, and India) in pharmaceutical formulation plants, Product Development; Analytical development; Scale-up, Technology transfer; Manufacturing, Quality Assurance; quality control (testing and releasing); Lead regulatory audits and meet the…
Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. She has worked…
Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry
He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11. He has developed advertising campaigns, written copy for advertisements and managed the creative development of advertisements.…
Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects,…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Steel Applications using Engineered Alloys with Heat Treatment and Welding Knowledge
Most of his metallurgical practice and experience since 1985 has been with steel and other iron based metal products. His limited exposure to other metal products such as aluminum and titanium, etc, would be sufficient to provide basic information about…
Aquaculture Freshwater Marine Production and Processing; Project Marketing Quality System; Fisheries
He is committed to work for total fishery aquaculture project as a main concept. Clients frequently ask him to prepare fishery project from concept, execution, training, equipment supply and start-up phases including marketing. He is responsible for the complete project…