Nitin Kumar
Director, Business Excellence
Expertise:
Nitin is an accomplished professional with over 20 years of experience spanning Good Vigilance Practice (GVP), Good Clinical Practice (GCP), bioanalytical science and software validation. He previously held the Senior Manager – GVP QA role at Sun Pharmaceutical Industries Ltd., the world’s fourth-largest generic pharmaceutical company and the largest in India. In that position, he led the pharmacovigilance QA team and oversaw global audits at more than 165 sites, including internal operations, contract service providers and business partners.
With extensive expertise in regulatory inspections, he has successfully navigated more than 25 PV inspections conducted by renowned agencies such as the U.S. FDA, Health Canada, MHRA, ANSM, PMDA, TGA, and ANVISA. He also designed and implemented a Global Compliance Oversight Program, ensuring ongoing monitoring of the pharmacovigilance system and achieving a state of “all-time ready” for inspections.
Nitin earned his bachelor’s and master’s degrees in pharmacy from Jamia Hamdard in New Delhi and is a Pharma (Pharmaceutics) ISO 9001:2015 certified lead auditor. As a life member of the Indian Society for Clinical Research (ISCR), he is actively involved in advancing the field through thought leadership and as a distinguished speaker at academic and industry forums.
Articles by Nitin Kumar
Staying Ahead of the Curve in Pharmacovigilance: Inspection Metrics Report for 2023 by Egyptian Drug Authority (EDA)
In an era where patient safety and regulatory compliance are more critical than ever, staying informed about global pharmacovigilance trends is essential. The Egyptian Drug Authority (EDA) recently released its 2023 Pharmacovigilance Inspection Metrics Report, offering a detailed look at inspection outcomes, key findings and areas for improvement. Our experts break down the highlights of […]
Staying Ahead of the Curve in Pharmacovigilance: ANVISA RDC No. 967/25
As the regulatory landscape continues to evolve, staying compliant with new pharmacovigilance requirements is more important than ever. Our Pharmacovigilance experts actively track evolving global regulations—so you don’t have to. What You Need to Know About ANVISA RDC No. 967/25 and Its Impact on Pharmacovigilance What is ANVISA RDC No. 967/25 and when does it […]
Staying Ahead of the Curve in Pharmacovigilance: Decentralized Manufacture — UK Guidelines of Good Pharmacovigilance Practices
Our Pharmacovigilance experts actively track evolving global regulations—so you don’t have to. To help simplify pharmacovigilance, we stay ahead of new regulations and guidelines, assess their impact and recommend actions that empower professionals to update their MAH systems, processes and procedures to ensure consistent compliance and drug safety. What is Decentralized Manufacturing (DM) and why […]
Staying Ahead of the Curve in Pharmacovigilance: Outcome of GVP Inspections by NPRA
Our Pharmacovigilance experts actively track evolving global regulations—so you don’t have to. To help simplify pharmacovigilance, we stay ahead of new regulations, assess their impact on current practices, and recommend actions that empower professionals to update their MAH systems, processes, and procedures to ensure consistent compliance and drug safety. This week, we examine the latest […]