About Regulatory Affairs

A Leader in Global Regulatory Affairs and Compliance

Regulatory affairs plays a vital role in ensuring safe and effective healthcare products are available worldwide, and Genpact Pharmalink provides the global regulatory compliance expertise that today’s leading pharmaceutical companies rely on. Recent advances in science and technology, and an increasing focus on drug safety have put regulatory affairs at the center of the development of new therapies, drug products and medical devices around the world. Concurrently, the passing of the era of blockbuster drugs mandates that pharmaceutical companies focus on products with smaller ROIs, increasing the importance of efficient development and manufacturing, two critical components of the regulatory affairs realm. That’s why the top healthcare companies trust Genpact Pharmalink to meet their regulatory affairs needs – Globally.

Guidance for Pharmaceuticals and Medical Devices Regulations

We offer local Regulatory Affairs expertise when and where clients need it, in 115 markets ranging from Argentina to Zambia. Our professionals – many of them former regulatory agency staffers – understand the cultures, the market nuances, and how to ensure client requirements and those of licensing agencies are both met. With team members ranging from Subject Matter Experts to Junior Consultants, and Specialists to Generalists, we can assist with projects of any scale or length. Whether on-site or remote; a domestic, international, or multinational assignment, we save our clients time and money, and can make the difference between success and failure in securing necessary approvals for client products. If your company needs regulatory affairs assistance anywhere in the world, talk to Genpact Pharmalink, and learn more about the value our team can bring to your team.