Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

Medical Writing Services

Medical Writing Services

Medical writing services are a core offering at IMPACT. We know that quality is the most important factor in producing any document.  At IMPACT, our highly experienced team of medical writers is committed to providing you with clear and concise documents that are sound from both a scientific and regulatory perspective.

Extensive Experience

IMPACT’s medical writing staff has significant experience authoring a variety of regulatory documents across a wide range of therapeutic areas and all phases of development.  Our team at IMPACT has authored hundreds of clinical study reports (CSRs), clinical protocols, Investigator Brochures, and components of Investigational New Drug (IND) applications.

In particular, IMPACT has extensive experience authoring the clinical components of marketing applications, including New Drug Applications (NDAs) and Biologics License Applications (BLAs) in the US and Marketing Authorization Applications (MAAs) in Europe.  Collectively, IMPACT’s staff has written portions of more than 50 marketing applications.

Following the submission of NDAs and BLAs in the US, IMPACT is frequently asked by our clients to assist them in authoring Briefing Documents in support of FDA Advisory Committee Meetings.

Document Types

IMPACT’s medical writing services include, but are not limited to, authoring the following document types:

  • Marketing Applications
    • Integrated Summaries of Efficacy (ISE) and Safety (ISS) for US submissions
    • Clinical Components of Common Technical Document (CTD) Module 2: Clinical Overview (Module 2.5); Summary of Clinical Efficacy (Module 2.7.3); and Summary of Clinical Safety (Module 2.7.4)
    • Nonclinical and Clinical Pharmacology Summaries and Overviews
  • CSRs (across all phases of development)
  • INDs and IND Amendments
  • Orphan Drug Applications and Annual Reports
  • Investigator Brochures
  • Clinical Protocols and Amendments
  • Safety Narratives
  • Development Safety Update Reports (DSURs)
  • IND and NDA Annual Reports
  • Regulatory Agency Briefing Documents
  • Advisory Committee Briefing Packages
  • Pediatric Study Plans (US)
  • Pediatric Investigation Plans (PIPs) (EU)
  • Medical Communications

Procedures to Ensure the Highest Quality

IMPACT has standard operating procedures in place to ensure all documents undergo thorough quality control and scientific reviews prior to delivery to our clients.  We can prepare your documents using our suite of ICH-compliant templates and style guide or using Sponsor-provided materials; in either case, our team produces documents that are of the highest quality with regard to formatting and style as well as scientific content.

Is your team in need of medical writing services? If so, please contact us. We look forward to discussing your specific project needs with you.

For specific examples of our medical writing services, please check out our case studies and testimonials.