Preparation and Coordination of Submissions

Setting strategies and writing target product profiles is one thing. Doing the actual work is another. We can support you in preparing documents, compiling submissions and coordinating the review process.

Contact a consultant

Submissions and documents we can help with

Regulatory submissions are cross-functional endeavors. Many of the documents within each submission require teamwork between several of our departments, including Regulatory Affairs, Drug Development and Biostatistics. 

  • Clinical Trial Application (CTA)
  • Investigational New Drug Application (IND)
  • Orphan Drug Designation (ODD)
  • Pediatric plans (PIP/iPSP)
  • Fast Track and Breakthrough Therapy Designation
  • Priority Medicines (PRIME)
  • Market Authorization Application (MAA)
  • New Drug Application (NDA)
  • Biologics License Applications (BLA)

Where to begin? A first meeting is a good start 👇

Contact our director of Regulatory Affairs

Send your inquiry to Erika Spens

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