Medical Writing

 

We offer a full range of support for the creation and/or review of clinical and regulatory documents.  

 

Clinical Development Documents

  • Clinical Development Plans
  • Target Product Profiles
  • Full Synopsis, Protocol, and Amendments
  • Safety Narratives
  • Investigator Brochures
  • Informed Consent Documents
  • Annual Safety Reports

 

Regulatory Submission Documents

  • Clinical Trial Applications
  • Marketing Applications
  • Regulatory Briefing documents
  • Responses to Regulatory Authority and Agency queries
  • Special Designation applications
  • Product Labeling

 

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