• New drug application (NDA) / marketing authorisation application (MAA) / biologics license application (BLA):

  • Module 2.5 (clinical overview)

  • Module 2.7.4 (summary of clinical safety)

  • Module 2.7.3 (summary of clinical efficacy)

  • Integrated summary of safety (ISS)

  • Integrated summary of effectiveness (ISE)

• Clinical study reports

• Clinical study protocols / amendments

• Briefing documents

• Investigator’s brochures / updates

• Special designation applications

• Responses to regulatory information requests

• Development safety update reports

• Narratives

Something else? Please contact to discuss.

Writing Process Leadership

• Review existing program documents, including regulatory history

• Assess document development pain points and implement solutions in real-time

• Lead kickoff meetings

• Generate timelines

• Author first drafts and incorporate revisions following each review

• Route documents for review (eg, Veeva, PleaseReview, SharePoint)

• Schedule and lead adjudication meetings

• Format and align documents with templates and style guide

• Perform quality control

• Develop and maintain style guides, templates, and standard operating procedures