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Who We Are: Arunava (Ron) Sanyal, M.Pharm ,CQE, RAC CEO/President www.globalinkfdaconnection.com 7/17/2015 1 Introduction 7/17/2015 Ron Sanyal M. Pharm, CQE, RAC, is currently a Pharmaceutical Consultant located in Raleigh (Research Triangle Park) in North Carolina, USA. Ron is the President/CEO of GloabaLink Consulting, Inc. Twenty-five (25) PLUS years of "Regulatory Affairs" and “Quality Assurance” management level experience in Pharmaceutical, Biological, Nutritional, Medical Device (Implants) and In Vitro Diagnostic Industry. International Registrations experience with regulatory affiliates in China, Taiwan, Thailand, Malaysia, India and Japan. 2 Who We Are: 7/17/2015 He is a Subject Matter Expert (SME) on FDA’s Risk Management Program. Ron’s expertise includes Corporate Quality and Regulatory Compliance in the field of GXP (GMP, GLP, and GCP). In addition, he has successful track record on Product Submission (IDE/510(K)/ IND/PMA/) to US FDA and obtaining Product Approval for US Market in record time. He has an excellent rapport with FDA Officials. (Reviewers/ Inspectors). Expertise includes FDA’s Pre Approval Inspection (PAI) of the facility prior to Product Approval and Corporate Regulatory Compliance Audit. 3 Who We Are: 7/17/2015 Ron has worked for Multinational Corporation like Bayer, Mallinckrodt, AKZO Nobel, Organon Teknika, BioMerieux, and Biogen Idec. Mr. Sanyal has a Masters Degree in Pharmacy, is a Certified Quality Engineer (CQE-ASQ) and Regulatory Affairs Certified (RAC). He has worked extensively in the Pharmaceuticals, Biological, Medical Device and In Vitro Diagnostic product submission process pertaining to: International Product Registrations, Establishment License Application (ELA), Investigational New Drug (IND), Investigational Device Exemptions (IDE), Biologic License Application (BLA), Premarket Approval (PMA), and Premarket Notification (510K). He has worked in collaboration with FDA on the Safe Medical Devices Act of 1990, FDA Rules on 510(K) Summaries and Statements, Free Sale Certificate, Export Permit, Import Permit, FDA's "Refusal to Accept Policy" on submission like 510(k), PMA, IND, PLA, ELA, Blood Bank Stand Alone Software 510(k) submission, Clinical Site Audit, and MedWatch 4 Who We Are: 7/17/2015 Ron has been promoting India to US Pharmaceutical, Biological and Medical Device and In Vitro Diagnostic Industries through series of professional presentation organized by Regulatory Affairs Professional Society (RAPS). In January 1998, he led a private US Trade Delegation to India on Medical Device, Software and Food processing. Ron brings positive energy, team work, mutual respect and success to any organization he chooses to assist. 5