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

[WEBINAR] How to Assess Your CER for MDR Readiness Part 1: State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review

Join our President, Laurie Mitchell, on April 29, 2020, at 11AM PST / 2PM EST to align your CER with some key MDR requirements. This live webinar will help you assess your CER and identify possible gaps for mitigation before submission.

Attendees are eligible for a free consultation and scan of their CER (or CER template). Spots are limited – click to register for this free webinar.