Regulatory Writing
Regulatory Writing
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
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 25 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.