Regulatory

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.

Latest Articles

APIs for Pharma Applications

Explore our broad portfolio of API Vitamins, Lipids and Novel APIs

Latest Scientific Research

Our whitepapers summarize the latest research developments, covering key topics in the industry

Quick Links

Webshop

Request samples, place orders and view product documentation

Catalogue

Download the latest copy of our Solutions Catalogue

Contact Us

We’re more than a partner. We’re a competitive edge.

Whitepapers

The latest in vitamin and lipid research and industry developments

Webinars

Academic studies and the latest science in educational modules

Videos

Videos exploring the growing role of vitamin APIs and lipid API intermediates

This website does not constitute a recommendation or guidance for decisions concerning the purchase, use or application of products and does not relieve the user of the product of the obligation to undertake its own suitability, performance, quality testing or country specific regulatory approvals.  DSM Nutritional Products AG and its affiliated companies (hereinafter “DSM”) makes no representations or warranties, either express or implied, of merchantability, fitness for a particular purpose or of any other nature with respect to information or the products to which the information refers.  All trademarks, product names, symbols and graphics appearing on this website are the property of DSM.

Read more