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Medical Writing

ProPharma Group’s writers, editors, and quality reviewers know what it takes to produce clear, concise text for your clinical, scientific, and regulatory needs.

ProPharma Group: Your Expert Medical Writing Partner

Regardless of where you are in the development of your product, our team of medical writers has the expertise you need. Some of our medical writing-related services include:

Clinical and Nonclinical
  • Biologics License Applications (BLAs)
  • NDAs (Modules 1-5)
  • Clinical Study Reports (CSRs) and narratives
  • Regulatory responses
  • Transparency and Clinical Trial Disclosures (CTDs) and posting
  • Drug Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs)
  • General investigational plans
  • Informed consent forms
  • Investigator Brochure (IB) submissions
  • Protocols and amendments
  • Medical device Clinical Evaluation Reports (CERs)
  • Pediatric Indication Plans (PIPs)
 Project Support
  • Compilation, hyperlinking, and publishing
  • Word processing and formatting
  • Style-guide and template creation
  • Content editing & proofreading, including a QC review of data against the text and source documents
  • Literature searches, analysis, reference libraries, and citations
  • Standard operating procedure (SOP) development
  • Populating tables and building figures
  • Abstracts
  • Posters
  • Manuscripts
  • Publication strategy
  • Continuing Medical Education (CME) program planning
  • Whitepapers
Contact Us

Need Help With Your Clinical Trials?

Complete the form or call us at 877-808-5675 to discover we can assist at any phase of development.

Interested in gaining an industry edge? Let us help you stay current.

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