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Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Scientific, Clinical, Medical, and Regulatory Affairs
Expert is a senior executive and a global biomedical leader with expertise in all facets of basic, pre-clinical, clinical research, and regulatory science for drug, biologic, therapy, vaccine, and medical device development. Expert is a leader in strategic planning and…
API Polymorphism, Salt/Cocrystal selection, Physicochemical characterization, Crystallization and Precipitation Processes
A highly accomplished scholar, scientist, and inventor with over 45 years of balanced international experience in both academic and industrial research on crystallization and precipitation processes. As an academic, for combined 15 years, taught chemical engineering at Wroclaw University of…
HPAPIs, Pharmaceutical
Imaginative and resourceful professional with multi-faceted leadership experience in project/program management and drug development and manufacturing. Possesses key business skill sets including: strategy planning and execution, new product development, negotiation and influencing, and continuous process improvement. Strong technical skills to…
Medical Oncology: Patents, Medical Malpractice, Drug Development, Strategy, Biomarkers, and Theranostics
Expert possesses nearly two decades of experience in oncology and drug development. He is currently leading the clinical sciences program for a biotech company focused on CAR-T therapy for cancer. Before that, he served as the Director of Phase I…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Polymer chemistry, Organic chemistry, Analytical chemistry
Qualifications in brief: Industrial experience in Emulsion Polymerization and solution polymerizations: Product & applications development, scale-up, and customer service; Organic synthesis & Scale-up; Taught senior level polymer chemistry and organic chemistry courses; Ph.D. in Organic chemistry. • Organic and polymer…
All Aspects of the Restaurant Industry: Foodservice, Retail, QSR, FSR, Supermarket, Packaging, Bagged Ice
Expert is a senior leader with a proven track record of delivering results and achieving double-digit growth. His expertise encompasses all aspects of the restaurant industry. This includes improving business operations, as well as developing strong sales teams and transitioning…
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…
Regulated and Hazardous Materials Auditing, Compliance, Programs, Processes and Training
Expert has utilized his scientific and logistics experience to analyze and consult regarding materials that were thought to be difficult or "impossible" to produce or ship in normal modes commerce. With an intimate knowledge of material and production processes he…