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Global
Omega-3

Omega-3 Regulatory Affairs

Global
Omega-3

Regulatory affairs for omega-3 products

Our experienced regulatory staff work exclusively with omega-3 products and support all regulatory activities.

Long experience combined with regulatory intelligence and awareness enable us to set regulatory strategies and be advisors for internal and external projects and partners. We know the processes and work closely together with the manufacturing sites to find the best solutions for our products. We work with partners all over the world to establish the right regulatory strategies and ensure appropriate standards for our dossiers.

Why BASF

  • Regulatory affairs dedicated to omega-3
  • More than 25 years experience with regulatory procedures in the US, Asia, Europe and the rest of the world
  • Long experience in cooperating with customers, partners and authorities all over the world

We take care of the product lifecycle management for omega-3 products. 

  • Initiate and follow up regulatory procedures in all markets
  • Ensure regulatory compliance for the documentation of omega-3 pharmaceuticals and consumer’s health products
  • Establish and support dossiers for drug substance (DMF, ASMF, JMF, CEP etc.), drug product, marketing authorizations (MAs) and clinical trials  
  • Maintain clinical and non-clinical documentation for omega-3 drug products. 

CEP numbers and DMF numbers

  • Omega-3-acid ethyl esters 90
    • R1-CEP 2008-132-Rev xx
    • R1-CEP 2008-330-Rev xx
  • US DMF no 026056 (K85EE)
  • US DMF no 023369 (46/38 EE)
  • US DMF no 023911 (EPA 96 EE)
  • US DMF no 023510 (400/325 EE)
  • US DMF no 029192 Omega-3-Acid Ethyl Esters Capsules