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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…
Aquatic Safety: Swimming, Drowning, Cervical Spine/Diving, Boating, Hypothermia, Alcohol, and PFD\’s
Expert retired as a U.S. Coast Guard Commander. His last tour of duty was as Chief of the Boating Safety Division, Second Coast Guard District. As such, he was responsible for overseeing federal boating safety efforts in education, engineering and…
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…
Petrochemical, Pulp & Paper, Distillation, Industrial Accident Investigation, Overpressure Investigation and OSHA Compliance
Expert has over 40 years' of engineering design in the Chemical Process and Pulp and Paper fields. He has held positions of Production Engineer, Technical Director, Quality Control Engineer, Process Engineering Department Head, Senior Engineer. His experience includes many years…
Board Certified Internist with 22 yrs exp in Occupational Med including work site and drug testing.
A Board Certified Internist and Certified Medical Review Officer, Expert has 22 years experience in Occupational Medicine. Expert began working for industry as a staff physician for AT&T and then became plant Medical Director for General Motors. While at GM,…
Pharma-BioTech Clinical Trial Development and Drug Safety, Medical Monitor
Dr. received her M.D. degree from the University of Utah School of Medicine in 1988. She then completed training to practice in remote rural communities through a program at the McKay Dee Hospital for three years as a board certified…
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…
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…
Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…
Pharmaceutical Formulations, Nutraceutical Formulations
Expert is an expert in developing multi-source drug formulations and generic equivalents of innovator products. To date, he has developed and put into the international market more than 100 such products. Consultant to Zim Laboratories Ltd. from 1994 to 2000…