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Expert in 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…
Expert in SVP and GM, Growth
Executive in the technology industry with over 20 years of operational experience owning P&Ls and leading teams in go-to-market, general management, product, and business operations. Currently serving as the general manager driving product-led growth for Employer's SaaS business. Have led…
Expert in Psychology, Internal Medicine, Rheumatology, Clinical Medicine, Chronic Pain Management
Expert is a Board-Certified Rheumatologist (additionally with Boards in Internal Medicine). He possesses extensive experience and expertise in Immunology as well. Expert's official title is Associate Clinical Professor of Medicine and Cedars Sinai Medical Center. He is also self-employed. Appropriately,…
Expert in Formulation Liquids, Soft Gelatin, Two-piece Hard Capsules, and Process Development in Pharma
Expert has developed Soft Gelatin Capsules containing non-aqueous solution, suspension and self-emulsifying formulations for a variety of new chemical entities (NCE), prescription, highly insoluble compounds and OTC drugs. This experience included conducting solubility studies with hydrophilic/lipophilic excipients, as well as…
Expert in Sterile Compounding, USP 797/795/800, Home Infusion, TJC/ACHC/BOP Regulations, Healthcare/Change/Project Management, Acute/Hospital Pharmacy Management, Pharmacy Automation, Mail Order Pharmacy, DME
Expert is an experienced PharmD, Director of Pharmacy and Assistant Clinical Professor with 6 years of experience at small, medium, large, level 1 trauma academic, acute care and long-term acute care hospitals. She has deep experience in pharmacy operations, finance,…
Expert in Retail Pharmacy, Drug to Drug Interactions, Medication Management Therapy
Expert has had to deal with the retail aspects of PBMs from their infancy since he owned an independent pharmacy for thirty years before selling it to CVS. The PBMs have consolidated and the big players such as Medco, Caremark,…
Expert in Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training to include auditing in…
Expert in Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
Expert in Clinical Epidemiology, Public Health Medicine, Drug Safety, Clinical Trials
Expert is Director of Pharmacoepidemiology in a Public Health Consultancy providing advice and expertise to the public, regulators and medical professionals on the evaluation and safety monitoring of drugs in the European Community. He has: conducted state-of-the-art pharmacoepidemiological studies including…
Expert in wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…