Medical Writing Services

Medical writing is an essential part of clinical research, which requires expert knowledge to analyze and prepare complex regulatory documents. 

ProPharma Group is a global leader in pharmaceutical consulting with over 35 years of experience, and our medical writing team has the expertise to assist with the development of your product. Our team of writers, editors, and quality reviewers knows what it takes to produce clear, concise text for your clinical, scientific, and regulatory needs.

No matter where you are in the development process, we can act as an extension of your team to support your initiatives and achieve a successful outcome with regulatory agencies.

ProPharma Group: Your Expert Medical Writing Partner

As a leading pharmaceutical consulting company with global resources, we have expansive capabilities and a wide variety of medical writing services to meet your needs. From general guidance on strategy and formatting to specific projects like submissions and assessments — we can support your organization and adapt to changing needs throughout the development process. Our medical writing 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

 Publications

  • Abstracts
  • Posters
  • Manuscripts
  • Publication strategy
  • Continuing Medical Education (CME) program planning
  • Whitepapers
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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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