Clinical Regulatory Document Writing for Submission.


Medical Writing Services for Clinical Trials & Regulatory Submissions

We provide medical writing service for all phases of development for indications ranging from rare genetic diseases to large global trials. We employ efficient processes for any project large or small.

As GCP experts, we have an in-depth understanding of document guidelines in multiple therapeutic areas.

We are flexible in our approach and can work independently or collaborate with our clients based on their unique requirements.

We write and/or QC all of the following documents:

  • Regulatory submission-ready documents (including IND, CTA, NDA/sNDA, BLA, MAA, JNDA)
  • CTD Module 2 Documents
    – Section2.5 (Clinical Overview)
    – Section 2.7.1 (Summary of Biopharmaceutic Studies)
    – Section 2.7.3 (Summary of Clinical Efficacy)
    – Section 2.7.4 (Summary of Clinical Safety)
  • CTD Module 5 Documents
    – Integrated Summary of Efficacy (ISE)
    – Integrated Summary of Safety (ISS)
  • Clinical Study Reports (CSRs) (Phase 1, 2, 3, and 4)
  • Clinical Protocols
  • Investigator Brochures and Updates
  • Patient Narratives
  • Regulatory briefing documents  (eg, End-of-Phase 1, 2, or 3, Pre-NDA, and Advisory Committee)
  • Development Safety Update Reports
  • Risk Benefit Assessment

Quality Control

Our quality control process is designed to identify and correct inadvertent errors. With a wealth of knowledge and experience, our QC expert reviews benefit our clients at every phase of clinical development.

In addition to the documents listed previously, we also QC the following:

  • Statistical Analysis Plans
  • Mock Tables Listings, Figures
  • Draft Tables Listings, Figures
  • Final Tables Listings, Figures
  • Nonclinical Summaries

To learn more about how we can help your organization or request a quotation, please call us at 610-296-1747.