eCTD format errors, Module 3 CMC gaps, weak Investigator Brochures — these are the top three reasons FDA Refusal-to-File letters land on biotech desks. This results in a loss of 6-12 months and over 2 million dollars due to delays for Sponsors.
Our solution
Full eCTD authoring across Modules 1–5 for IND, NDA, and BLA submissions. Our packages clear administrative review the first time.
We author CTD modules 1-5, manage your life cycle submissions and conduct pre-IND type A/B meetings and EMA scientific advice concurrent with your FDA meeting(s).
Process
How we run this engagement.
Discovery
Submission readiness and gap audit
Strategy
eCTD architecture and Module 3 outline
Authoring
Module 1-5 documentation
Agency liaison
Pre-IND and Type B meetings
Lifecycle
Annual reports, IND amendments
eCTD authoring, publishing and FDA correspondence.
How we help
Full eCTD authoring & publishing — Module 1 through Module 5 — with FDA-compliant Lifecycle Management.
