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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Pharmaceuticals
PROFESSIONAL EXPERIENCE: Development, implementation and monitoring of clinical pharmacy services consistent with current practice guidelines for the following units: Neonatal Intensive Care, Pediatric Oncology, Pediatric Surgery, Pediatric Emergency Medicine, General Pediatrics, and Pediatric Intensive Care units. Formulary management and drug…
Food and Beverages, FMCG, Dairy and Milk, Agri-Business, Chemicals, Specialty Chemicals, Pharmaceuticals, Health Care and Medical Devices, Industrial Chemical Ingredients
Expert has 34+years of extensive industry experience, is a Highly Qualified, Senior Professional Consultant, and is well known internationally. He has a Graduate Degree in Agricultural Technology-B.Sc. (Agri Tech); an MBA (Masters in Business Administration) and a Ph.D. (Doctor's Degree…
Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Pharmacokinetics/Pharmacodynamics
Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a…
Pharmaceuticals
During Expert’s 30 years in Pharmaceutical Research and Development, he developed extensive expertise in novel drug delivery systems and assessing external drug delivery companies while at Parke-Davis/Warner-Lambert, Pfizer and SCD Pharma Consulting. He also managed a team of scientist developing…
Pharmaceutics
Excipients are broadly defined as any pharmacologically inert components other than the active pharmaceutical ingredient (API) that are added intentionally to the pharmaceutical formulations. Unintentional variability in the properties of the excipients may have a range of influences on their…
Biotechnology, Pharmaceuticals,
Expert in Biopharmaceutical molecule development and licensure. Experience with top Biotech companies (BMS, sanofi, MedImmune, AZ, Adello, etc.). Designed successful Analytical strategy for 100s of IND and many BLA submissions in multiple countries. Expert in the following areas: Scientific writing…
Pharma/Biotech Market Access, Pricing & Reimbursement, Business Development Europe and Latin America
Pharmaceutical executive with 17+ yrs. experience in international, corporate and local/regional roles at leading pharmaceutical companies in Europe and Latin America. Strong experience in general management, business development and licensing, alliance management, project and transition leadership, marketing and sales, strategic…