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Regulatory Submission Writing

Our services include:

  • Clinical and Non-clinical writing
  • Briefing Books/Meeting Requests
  • Assessment Aids/RTOR packages
  • IRs, Response to Questions
  • IND, CTA content
  • NDA, BLA, MAA, PMA content
  • General Investigational Plan (1.13.9)
  • Non-clinical Overview (2.4)
  • Non-clinical Summaries (2.6)
  • Clinical Overview (2.5)
  • Clinical Summaries (2.7)
  • Integrated Summary of Safety (ISS)
  • Integrated Summary of Efficacy (ISE)
  • Orphan Designation
  • Fast Track/ Breakthrough, Accelerated Approval
  • iPSP/ PIP
  • Literature Review
  • Style Guide Creation

Contact us today

For more information on Regulatory Submission Writing, please fill in the form and we will respond to you as soon as possible.

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