Medical Writing

Medical Writing

MEDICAL WRITING

At IMPACT, writing is our core competency. Impact writers have extensive experience supporting clinical documents from IND submission through post-marketing commitments.  Impact writers have key essential skills that ensure messages are consistent, concise, and complete.  We have extensive drug development experience.  Our writers bring regulatory knowledge, medical writing professionalism, drug development experience, and the ability to communicate effectively across multidisciplinary departments.  We can provide a single writer to support multiple documents, we can implement document review and approval processes in your department, we can create document templates to support your internal teams, and we can provide guidance and expertise as you begin to generate clinical data.

All IMPACT employees are trained in industry best practices and our SOPs. We provide the ultimate in quality control with the ability to meet your rapid and aggressive timelines.

NEED HELP?

Let's discuss your project needs.

Let our team help you with:

  • IND Modules 1-5
  • Protocol Synopses
  • Protocols
  • Protocol Amendments
  • ICFs
  • Investigator Brochures
  • Pre-Meeting Packages
  • Pediatric Investigational Plans
  • Briefing Books
  • Clinical Study Reports
  • FDA Response Documents
  • Safety Narratives
  • Investigational New Drug (IND) applications
  • New Drug Applications (NDAs)
  • Biologic License Applications (BLAs)
  • Marketing Authorization Applications (MAAs)
  • Model documents/templates
  • Toolbars
  • Publishing