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Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market
Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO, Government of India for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs. Expert was the Medical Devices Reviewer for…
FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. He serves on multiple brand advertising and promotional…
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…
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…
Anesthesiology, Pain Medicine (Chronic/Acute), Perioperative Medicine, Clinical Research, Regulatory
ANALGESIA - Expert has extensive experience in analgesic research, drug development, regulatory affairs (including REMS) and marketing. He is an author for various publications, and presentations on different classes of analgesics. He has a vast amount of clinical experience with…
Product Safety Regulatory Compliance
He has performed evaluation and testing for both regulatory safety standards such as UL, CSA and IEC standards and in component failure analysis. As a part of his regulatory expertise he has - evaluated and performed testing for shock hazards…
Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. She has worked…
EMI/EMC & RF Compliance Testing/Worldwide Regulatory Project Management
Setup a Bluetooth RF & Protocol Qualification Test Lab. Was a Bluetooth Qualification Body (BQB) for 2 years. Performed and Managed FCC/CE/IC Regulatory Compliance Testing for various types of Bluetooth Module and End Products. Paticipated in many Bluetooth Expert Meetings.…
Biotechnology, Enzymes, Environmental Bioremediation, Regulatory Compliance
Expert has over 40 years of experience in both basic and applied Biochemistry (biochemical research and enzymology) and Biotechnology. He is very successful in finding flaws in published and spoken materials. His strengths are in the fields of physical biochemistry,…
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.…