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Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry
He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11. He has developed advertising campaigns, written copy for advertisements and managed the creative development of advertisements.…
Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects,…
Enzyme/Protein/Antibody Stabilization, Biosensor Development & Shelf-life, DNA Stability & Testing
He has to deal with evaluating new business ideas on a daily basis either via his new business or via his enzyme business. A number of new stabilization systems have been incorporated into new product lines as a result of…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Medical Devices, Electronic Systems, Acoustics and Hearing, Intellectual Property
Because of his long-term interest in sound and hearing, Expert has been involved with many aspects of acoustic measurement. He has developed proprietary technology for sound level measurement and noise dose determination and has utilized his skills in acoustic measurement…
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…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Nursing, Medical Literature, Healthcare
Expert started her career as a medical/surgical and hematology/oncology nurse working at Children's Hospital. She received her master's degree in (clinical nurse specialist and nurse practitioner) pediatrics from the University of Delaware. Expert went on to take a position at…
Medicine, Especially Pathology (Laboratory Medicine), Women\’s Health, Cervical Cancer, Breast Cancer
Expert has practiced diagnostic surgical pathology for over 20 years, with special interest and experience in gynecologic and gastro-intestinal pathology. She has participated in several clinical trials with pharmaceutical clients in these areas, and has practical knowledge of what is…
Cardiovascular Disease, Hypertension, Arrhythmiad, Congestive Heart Failure, Internal Med, Lipids
Expert is an expert in solo cardiology and internal medicine. He has his own practice with 25 years experience in clinical, pharmacologic, medical legal consulting. Ten years experience in medical clinical trials. He is an active expert for consulting, medical…