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Expert ID: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

Expert ID: 726401 New York, USA

Expert in Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products

Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups…

Expert ID: 722568 Delaware, USA

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms

As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…

Expert ID: 735397 Connecticut, USA

Expert in Pharmaceutical Development

He brings 38 career-years’ experience, including service at FDA as a Review Chemist. He began his career in pharmaceutical research and development with Purdue Pharma (Stamford, CT – MS-Contin®, Uniphyl®, Oxycontin®)(3 years), and continued on to Bayer (West Haven, CT…

Expert ID: 727750 Canada

Expert in 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…

Expert ID: 725331 California, USA

Expert in Medical Device Regulatory Submissions

She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…

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