Global Medical Writing

Regulatory Writing Services

Clear, accurate and compliant global medical writing services speed regulatory approval

Regulatory medical writing plays a large role across the evidence generation continuum. From generating clinical development plans and study protocols through the development of the Common Technical Document for NDA/MAA submission, regulatory medical writing is of key importance in developing and conveying the strategic message of the data. UBC’s team of medical writers offers comprehensive writing services that span the entire product lifecycle.

UBC Knows

UBC knows that regulatory documents must convey strategic safety and efficacy messages supported by clinical data. Our team of experienced medical writers consistently produces accurate and timely documents that are compliant with client and regulatory guidelines. UBC can provide the following documentation as a stand-alone offering or through our clinical trial offering:

  • Program-wide documents

    • Clinical development plans
    • Investigational New Drug (IND) applications
    • Investigator brochures
    • Common Technical Document (CTD)
    • Risk Management Documents, including Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs)
  • Clinical Study Documents

    • Protocols and protocol amendments
    • Safety and product reporting

      • Periodic Safety Update Reports (PSURs)
      • Development Safety Update Reports (DSURs)
    • Phase 1 through 4 clinical study reports and interim reports
    • Manuscript development, review and editing
    • Phase 4 observational studies and registries
    • Patient narratives and patient profiles

UBC Understands

The strength of medical writing relies on the experience and insight of the writers. All UBC writers have extensive experience writing Phase 1 through 4 clinical trial reports in a broad selection of therapy areas and indications. They are skilled in managing the document preparation, review, and finalization process, including management of document review meetings. The writing team can also adapt to sponsor organizational models and processes, while maintaining a high standard of quality and adherence to applicable regulatory guidance

Commitment to Success

Our writers have an average of more than 20 years of industry writing experience.

Contact Us

Put our global regulatory writing staff to work for your product. Contact us today.

 

Brochures

UBC Clinical Development Solutions

UBC Solutions