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