Regulatory Writing

Regulatory Writing

Medical Devices

Thera-Business will work with you to develop documents throughout the medical device development process. We can assist with:

  • Clinical Trial Protocols
  • Clinical Trial Applications (CTAs)
  • Investigator’s Brochure (IB)
  • Clinical Study Reports (CSRs)
  • IDE Submissions
  • 510(k) Submissions

Pharmaceutical / Biologics

Thera-Business will work with you to develop documents throughout the pharmaceutical drug/biologic development process. We can assist with:

  • Clinical Trial Protocols
  • Clinical Trial Applications (CTAs)
  • Investigator’s Brochure (IB)
  • Clinical Study Reports (CSRs)
  • IND/NDA/BLA Submissions
  • Prescribing Information
  • Periodic Safety Update Reports (PSURs)

Why Choose Us

  • We are detail-oriented team players who have been providing medical research and writing services to our clients across the globe for over 20 years.

  • We are experts in the development of well-written and accurate regulatory documents.

  • We have completed hundreds of projects for leading medical device and pharmaceutical companies, and government health agencies.

  • We are driven by the knowledge that our work is important and makes a difference to patient care.

We've completed 500+ projects for leading medical device and pharmaceutical companies, as well as government health agencies.