Regulatory

With a global network of regulatory specialists, we have the expertise and local knowledge needed to achieve cross-regional registrations. Our strong track record of successful registrations and close collaboration with various authorities, alongside continued investment into our production and operations, means we can meet the highest quality standards in each of our regions. 

Our API production is governed by a wide range of global certification systems to support the success of your pharmaceutical solutions. These include:

• GMP (ICH Q7) certified production
• Certificates of Suitability (CEPs)
• Compliance with various compendia: USP/EP/JP

We collaborate with a wide range of authorities, including the US Food and Drug Administration (FDA), European Directorate for the Quality of Medicines (EDQM), and Health Canada (HC), to ensure our products continue to meet standards worldwide.  Furthermore, DSM closely collaborates with various industry associations, including: 

• Active Pharmaceutical Ingredients Committee (APIC) 
• International Pharmaceutical Excipient Councils (IPEC) Federation 
  

Contact us to find out how our comprehensive regulatory support can benefit your project.