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Writing Solutions

Technical/Regulatory Writing

Preparation of internal and/or regulatory submission documents that are fit for purpose, scientifically sound, aligned with health authority requirements.  Some examples of these services include:

  • Clinical trial applications

  • License applications

  • Drug Master Files (DMF)

  • Post-approval supplements

  • Batch records

  • DSURs, annual reports

  • Investigations

  • Protocols, reports

  • SOPs, manuals, job aids

  • DEA Quota requests

  • Agency meeting requests, briefing books, and sponsor’s minutes

  • Responses to agency information requests, clinical holds, and complete response letters

  • Dedicated Quality Review Team specific to CMC projects

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