Who We Are:

1
Who We Are

• Arunava (Ron) Sanyal, M.Pharm ,CQE, RAC
• CEO/President
  www.globalinkonline.com

2
Introduction

• 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.

3
Who We Are

• He is a Subject Matter Expert (SME) on FDAs
  Risk Management Program. Rons 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 FDAs Pre Approval Inspection (PAI) of
  the facility prior to Product Approval and
  Corporate Regulatory Compliance Audit.

4
Who We Are

• 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

5
Who We Are

• 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.