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.
Abridged CMC Healthchek™
- No written report, 1hr discussion meeting
- Next steps – deeper dive into specific areas via T&M
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