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Achieving Regulatory Success Across Borders

 
 
 

But establishing a centuries-long track record of trust takes more than the broadest portfolio of indispensable ingredients or an ability to predict trends—it takes global regulatory proficiency. With our experienced global group of regulatory affairs experts, we help customers navigate regulatory compliance needs across borders and clear a path toward product innovation.
 

Understanding the Tools and Partnering with the Experts

We understand the complexities of the FDA’s Inactive Ingredient Database (IID), which enables us to support customers’ filings of bridging justifications and reduce the likelihood of receiving Refuse-to-Receive (RTR) or excipient-related deficiency letters.

We work closely with the IPEC to establish excipient stability guidelines that promote best practices for excipient quality and supply chain security around the world.
 

Navigating the Global Environment

We are at the forefront of the evolution of excipient regulations in China, ensuring that our partners can navigate the complex web of new regulations and guidelines and follow updated standards in the Chinese Pharmacopeia (ChP).

We appeal directly to the Food & Drug Administration (FDA) to create pilot programs that evaluate the safety, toxicology and quality of novel excipients intended for use in human drug products.
 

By Your Side…Assessing Risk and Find Solutions

Given the highly regulated nature of pharmaceuticals, it’s important to choose the right partner to assess risk and find the right answers for you.  For example, as numerous regulatory agencies are implementing requirements for Marketing Authorization Holders (MAH) to conduct risk assessments for possible presence of nitrosamines, we are supporting our partners every step of the way.

We have Nitrosamine Risk Evaluation questionnaires available for all of our pharmaceutical excipients in accordance with the IPEC guidelines, enabling our customers to assess this challenge.

We also partner with customers and offer expertise in regulatory and analytical sciences to further help navigate this territory.  

 
 
 
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