Regulatory Support

Proactive Regulatory Guidance Speeds Success

Accelerate your product’s journey to approval: Let Recro’s experts get you there faster.

From developing sound regulatory strategies to providing FDA meeting guidance and preparing submissions, our regulatory experts have the experience you need to streamline your product’s pathway to regulatory approval.

Our Approach

Recro’s regulatory experts collaborate with our scientists to guide all drug development efforts. As your product journeys toward approval, we collect the data you need, when you need it. We also anticipate challenges and navigate risks to achieve your program milestones. At filing time, you can count on our experts to guide you through the submission process and support your post-approval product needs.

Our regulatory solutions include:

  • Assistance with end-to-end filing strategies, including for global markets and specialty designations (e.g., orphan drug)
  • Early-stage and CMC guidance
  • Late-phase/NDA consultation
  • Planning and preparation of regulatory documentation (eCTD submission-ready)
  • FDA meeting guidance and support
    • Pre-IND
    • End of Phase II
    • Pre-NDA
  • Post-approval product management
  • 505(b)(2)

Take your regulatory strategy to the next level