FDA Submission Deadline & eCTD Document Tracker
A done-for-you pharma and biotech automation built for the Regulatory Affairs Manager, connecting Slack, Airtable, and Google Calendar so the work below happens on its own.
What this automation does, step by step
Every active IND, NDA, BLA, or 510(k) submission has a complete calendar of required actions, annual report due dates, response deadlines for FDA information requests, post-market commitment reports, and labeling update requirements, tracked in a central system with reminders at 90, 30, and 7 days before each date.
When an FDA complete response letter or information request is received, a structured response workflow is triggered automatically, assigning sections to the responsible regulatory, clinical, and CMC teams with deadlines calculated from the statutory response window.
No submission deadline is missed because it was buried in an email thread from three months ago.
- Regulatory information management system or Airtable (submission calendar)
- Zapier or Make.com
- Google Calendar (deadline entries)
- Email or Slack (team task assignments and escalating reminders)
- SharePoint or Veeva Vault (document repository)
Using different software? We build around what you already have, so you never have to switch tools to automate.
The manual way vs. the automated way
Without automation
Left unautomated, a regulatory affairs manager spends hours on the parts of this job that don't require judgment: copying data, sending reminders, and tracking status by hand. Over a month, those small manual steps add up to a significant amount of lost time.
With this automation
- Expiration and renewal alerts on a 90, 60, and 30 day countdown
- Signature and document chasers that escalate on their own
- Deadline tracking for filings, permits, and inspections
- An automatic audit trail of every notice sent
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