Gap Analysis and Risk Assessment Products

CMC Healthchek™

CMC Healthchek™ is a comprehensive gap analysis that looks at product development as a snap shot in time from the viewpoint of upcoming important milestones. The review is based on a list of documents requested by DSI and delivered by customer electronically. SME’s with appropriate expertise are assigned and a report with identified gaps and risks is supplied to customer as finished product.

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CMC Quickchek™

Abridged CMC Healthchek™

  • No written report, 1hr discussion meeting
  • Next steps – deeper dive into specific areas via T&M

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CTD Healthchek™

NDA/BLA Filing gap/risk analysis

  • Review filing sections by CTD format for completeness for filing
  • Final report template and review checklist based on CTD
  • Next steps – authoring or SME assistance to complete CTD via T&M or CTD Authoring product

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