Products / SubmissionVault
Every submission deadline, guidance update and renewal in one place.
SubmissionVault replaces the regulatory spreadsheet for small biotech and medtech teams and the consultants who support them. Log your products and submissions, and get reminded well before a decision window, annual report or renewal comes due.
- Regulatory affairs teams
- Medtech startups
- Emerging biotechs
- Regulatory consultancies
Built around how regulatory teams actually work.
Submission tracking
Track each product’s submissions across 510(k), PMA, De Novo, NDA, BLA, MAA and EU MDR, with status and supporting documents attached.
Deadline engine
Enter deadlines by hand or from templates that calculate due dates from a trigger date. Recurring deadlines roll forward when marked done.
Reminders that reach you
Email and browser push reminders, a personal calendar feed, and alerts to a shared Slack or Microsoft Teams channel.
Guidance watchlist
Keep a running list of the FDA and EMA guidance documents your team is following, with a review status for each.
Made for consultancies
Group products and deadlines by client company, and limit each associate to the clients they work on.
What’s due next
A dashboard color-coded by urgency, so the week’s priorities are obvious at a glance.
Up and running on day one.
Add your products
Enter them one at a time, or import a spreadsheet on the Team plan.
Log submissions and deadlines
Use templates for common deadlines so due dates calculate themselves.
Get reminded early
By email, push, calendar or team channel, well before each date.
Mark it done
Recurring deadlines roll forward to the next cycle automatically.
Your regulatory calendar stays yours.
SubmissionVault holds product and submission details, not patient data. Every organization’s records are kept separate, and you decide who sees what.
-
Roles for every teammateAdmins manage the account, editors keep records current, and viewers can look without changing anything.
-
Per-client accessRestrict an associate to specific client companies, so one client’s work is never visible to another’s team.
-
Single sign-onSign in with your identity provider (Microsoft Entra ID, Okta, Google Workspace or any OIDC provider) on the Team plan.
-
Separate data for every organizationRecords, attachments and calendar feeds are scoped to your organization on every request.
Simple, per-team pricing.
Every plan starts with a 14-day free trial. A card is collected at signup and isn’t charged until the trial ends, and you can cancel any time before then.
For a small regulatory team getting off the spreadsheet.
- Up to 3 seats
- 1 GB attachment storage
- Deadline tracking, reminders and guidance watchlist
- Email, push, calendar and Slack/Teams alerts
For larger teams and consultancies.
- Up to 5 seats
- 10 GB attachment storage
- Everything in Starter
- Single sign-on (SSO)
- Import products from a spreadsheet
Optional add-ons: Managed Onboarding, where we set up your account for you ($825 on Starter, $1,525 on Team, one time), and Priority Support ($115/month).
See SubmissionVault with your own deadlines.
Tell us what you’re tracking today and we’ll walk you through it.