Cedarburg Pharmaceuticals

Regulatory Services

You don’t have to navigate the complex FDA submission process alone.

If you need help preparing and submitting your API regulatory applications, Cedarburg Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.

You can rely on Cedarburg Pharmaceuticals for your regulation filing because we have:

  • Successfully filed multiple DMFs in North America and Europe.
  • Assisted our customers with writing CMC sections of ANDAs and NDAs
  • An excellent relationship with the DEA
  • Permits and quotas for Schedule II, Schedule III, Schedule IV and Schedule V controlled substances

With our strong history of regulatory compliance and our positive relationships with the FDA and DEA, Cedarburg Pharmaceuticals will help you smoothly navigate your API to market and/or prepare it for licensing.