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Regulatory Support

The pathway to approvals

Managing clinical outcome assessments (COAs) in all major geographies, we have developed solid relationships with global regulatory agencies and leading professional societies in the field. Our experience lends us an extensive understanding of regulatory processes and guidelines in the U.S. and other markets around the world.

 

To ensure the swift success of your research projects, we can provide expert guidance on regulatory compliance for every element of your COAs – from design to implementation, to analysis and interpretation.

Service Benefits

  • Preparation, attendance and participation in FDA meetings, such as End-of-Phase-2, Type B and Type C.
  • Strategic and tactical engagement with FDA staffers from CBER, CDER and CDRH, including the COA group and clinical review divisions.
  • Support on regulatory correspondence and meeting packages.
  • Development and review of COA evidence dossiers and COA label claim language for regulatory submission.

 

 

Strengthening regulatory strategies and submissions

Our regulatory insights enable more effective strategies for gathering evidence of treatment safety and efficacy, gaining marketing and clinical trial authorizations, and ensuring the success of post-licensing and post-marketing efforts.