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Pharmaceutical Development, strategy planning and execution
Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher…
Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer’s and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic’s regulations. Moreover, her firm has extensive experience in…
Clinical Laboratory Testing, Interpretation, Quality Assurance and Reporting.
Expert was trained in clinical chemistry and toxicology and is a Fellow of the American Board of Clinical Chemistry, Academy of Clinical Biochemistry and has over 19 years experience directing clinical laboratories including forensic (drug testing) facilities. Expert has a…
Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials
Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of pharmaceuticals. Trained in medicinal chemistry, Expert undertook clinical pharmacology research in a University Hospital for 12 years before joining the…
Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. Product development of foods and cosmetics. Management…
Women’s Health (Fertility/Infertility, Menopause, Osteoporosis, Hormone Therapy, Sexuality, etc.)
Expert is board certified in obstetrics and gynecology with a subspecialty in the Division of reproductive endocrinology by the American Board of Obstetrics and Gynecology. He received his MD in 1978 from Rush Medical College and completed his internship and…
Psychopharmacology, Drug Development, Medical Devices
Expert's training in psychiatry has focused on biological psychiatry (the biological basis of psychopathology) and on psychopharmacology. He currently directs the Developmental Biopsychiatry Research Program and the Laboratory of Developmental Psychopharmacology at McLean Hospital/Harvard Medical School. He has a broad…
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…
Clinical Anesthesiology, Surgical Recovery Room, Critical Care, Pain Medicine, Abused Drug
Current Practicing Anesthesiologist responsible for caring for individuals that use abused drugs on a regular basis. These individuals have both medical and psychological problems resulting from both recent and long term abuse of drugs. Treats individuals who receive care at…
Liver Iron, Phosphate Binder, Dialysis Membranes,CRRT, CVVHD, SHPT, Vitamin D, Transplant, Stem Cells, RNAi, Diabetic Nephropathy
Expert, MD, is an Associate Professor of Clinical Medicine and Nephrology at Keck Employer. Medical Director of CKD program Medical Director of PD and Home Hemodialysis full time attending and Medical School professor teaching responsibilities for medical students II-IV, interns,…