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Navigate agency interactions effectively and efficiently

Leverage the right expertise to keep approvals on track and bring drugs to market faster.

Navigating regulatory agency interactions is complex and represents significant investment for companies bringing new drugs to market. With thoughtful preparation, common mistakes can be avoided, saving you valuable time and money. YourEncore experts offer unique insight into how agencies, like the FDA, behave, how to earn their trust, and how to partner with them effectively. They can do this because they’ve sat in the chairs of agency officials and have been responsible for dozens of drug approvals over their 25+ year careers.

Expertise:

Providing specialized expertise and objective perspectives to ensure you are prepared for your next agency meeting.

  • Regulatory Strategy
  • AdComm Preparation
  • Submission Writing
  • Regulatory Communications
  • Pre-approval
  • Labeling & Promotions
  • Investigational New Drug (IND) Application
  • New Drug Application (NDA)/Biologic License Application (BLA)/Abbreviated New Drug Application (ANDA)
  • Investigational Device Exemption (IDE)
  • Premarket Approval (PMA)/510(k)
  • Rare Disease Development

Solutions:

We develop solutions that address the unique needs of each client, and then move quickly, efficiently, and effectively to deliver results. Contact us to explore how we can help.

  • Stage-gate/Due Diligence
  • Patient Safety and Regulatory Compliance

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