Quality /

Regulatory support

Regulatory support

We support our clients to ensure regulatory compliance with all applicable regulations. Our experts compile and review all data and documentation needed for regulatory CMS-submissions to help our clients to make their product a success in the market.

Main Regulatory Affairs support services:

  • Preparation of  documentation required for CMC part for IMPDs and BLAs / the registration of pharmaceutical products, as well as maintenance of the existing registrations
  • Confirmation that the pharmaceutical products are compliant with the strictest requirements for quality and safety
  • Ensurance of the quality, content, and format of regulatory submissions
  • Ensurance of  consistency, completeness, and adherence of standards for all submissions