Development & Strategy Interactions with Regulatory Authorities

Interactions with Regulatory Authorities

Our employees have served on US Food and Drug Administration (FDA) Advisory Panels including Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH), and they continue to frequently meet with regulatory authorities (FDA, European Medicines Agency [EMA], and many others) to discuss our sponsor’s products, regulatory strategies, and innovative pathway designs.

CTI has established long-term relationships with many key regulatory officials. Our relationships help to facilitate communication and build on expectations of quality products that are scientifically sound and clearly presented. Our team, including regulatory and medical experts, is adept at coordinating effective regulatory interactions and ensuring that the right questions are asked. This propels programs forward and minimizes the risk of study delays and clinical holds due to unforeseen regulatory issues.

Our interactions with regulatory authorities have included:

  • Advisory committee hearings
  • Clinical development planning meetings
  • End of phase II meetings
  • Issue resolution meetings
  • Pathway negotiations
  • Pre-Investigational New Drug (Pre-IND), Pre-Biologic License Application (Pre-BLA), and Pre-New Drug Application (Pre-NDA) meetings
  • Regulatory authority sponsored public workshops
  • Scientific advice meetings
  • Type A, B, and C meetings

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