Quality And Regulatory

CPC helps customers navigate the regulatory process to facilitate a successful product launch and life cycle.

CPC’s in-house experts are highly knowledgeable about regulatory requirements in worldwide markets. They work closely with customers around the globe to prepare U.S. FDA and international dossiers.

U.S. and international product registration support

  • Regulatory support for Abbreviated New Drug Application (ANDA), New Drug Application (NDA) and 505(b)(2) submissions
  • Change control and support of post-approval commitments
  • Post-approval stability testing and monitoring of product quality

CPC’s in-house regulatory experts monitor FDA regulations to ensure our strict compliance with current Good Manufacturing Practices (cGMPs).