Regulatory and Quality Services    

Bring your pharmaceuticals to market with confidence

Our global regulatory expertise, strict quality policies and advanced quality management systems give you the ultimate confidence that your drug formulations are compliant in fast-changing and complex local markets. 

With a strong track record of successful registrations and collaboration with regulatory authorities and government agencies across the world, alongside continued investment into our production and operations, we can meet the highest quality standards in each of our regions. Plus, our regulatory and quality team continually monitor changes in the market and adjust our services accordingly, providing customers with distinct competitive advantage. 

Explore our regulatory and quality services

GMP-certified ingredient portfolio

 Our global network of industry-leading GMP-compliant manufacturing facilities allows us to offer a consistent and reliable supply of active pharmaceutical ingredients that meet the highest quality and safety standards. Our production network complies with a comprehensive set of safety, health and environment policies (SHE). We are governed by a variety of certification systems, including ICH Q7 and the Certification of Suitability (CEP), and we ensure compliance with the US, European and Japanese pharmacopeias where applicable. 

Global regulatory expertise

With a global network of regulatory specialists, we have the expertise and local knowledge needed to achieve cross-regional registrations. We’re here to offer regulatory advice to help you navigate the ever-changing pharmaceutical landscape across multiple geographies and regions. 


 

Facilitate market entry

Our unparalleled ability to manage the market entry registration process means that we can facilitate successful market entry. At the same time, we realize the importance of continued success after launch too – supporting the growth and evolution of your product across the product life-cycle.