Regulatory & Medical Writing

Regulatory & Medical Writing

At Thera-Business, we offer comprehensive medical and regulatory writing services, combining our expertise in the fields of medical devices, pharmaceuticals, and biologics. Our highly trained team is equipped to support you through every phase of your product's development and regulatory process, ensuring excellence and compliance.

We specialize in a broad range of services, including:

  • Clinical Study Protocols & Reports (CSRs)
  • Investigator’s Brochures (IBs) & Clinical Trial Applications (CTAs)
  • Product Monographs, Package Inserts, Prescribing Information
  • 510(k) & CERs
  • IDEs, INDs, NDAs, BLAs
  • Standard Operating Procedures (SOPs)
  • Manuscripts & Conference Posters
  • Business Cases & White Papers

This overview encapsulates our core offerings, but our capabilities extend beyond what is listed here. We invite you to contact us for any specialized regulatory or medical writing needs.

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