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.

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

Contact us for a free consult on your current needs.

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] Driving Innovation to Success in the Market: Strategic Considerations.

Join us for our LIVE webinar on June 16, 2021, at 11AM PST / 2 Pm EST. In this engaging panel discussion, four industry professionals will discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries as well as key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets.

Attendees are eligible for a free consultation. Spots are limited – click to register for this free webinar.