Pharmaceutical and Biologics
Regulatory Writing

A Partner on Key Writing Initiatives

Document compliance with the requirements of the eCTD standards is mandatory for pharmaceutical and biologics regulatory writing. The regulatory writer must understand all aspects of the drug development process, from pre-clinical through submission and the regulations that govern the documents generated at each step.

The writers at Criterion Edge can partner with your internal team to help drive your regulatory writing projects to completion.

Listed here are just a few examples of the deliverables we can provide. If you have additional questions, please contact us. We’re available to discuss your team’s specific needs.

Learn more about the other Pharmaceutical/Biologics regulatory documents we support.

Pharmaceutical and Biologics Deliverables include:

  • Clinical Study Reports (CSR)
  • Annual Progress Reports
  • IND/NDA/BLA submissions
  • Integrated Clinical/Statistical Study Reports (ICSR)
  • Investigator‘s Brochure (IB)
  • eCTD, including Module 2 summaries (ISS/ISE), Module 4 and 5
  • Synoptic Reports
  • Risk Mitigation and Management Plans