qms-regulatory

Regulatory Affairs

Submit. Track. Comply.

The promise nobody remembered. Eighteen months later, the inspector asks about your commitment—nobody who made it still works here. Track every regulatory obligation with deadline countdowns.

The promise nobody remembered.

Eighteen months ago, response to a 483 observation: "We will implement a revised cleaning validation protocol by Q2 2024." Inspector accepted. Warning letter avoided.

Now it's Q3 2024. New inspector. "You committed to implementing a revised cleaning validation protocol. Show me the protocol."

The VP who wrote the commitment retired. The QA director moved to a competitor. The current team wasn't there eighteen months ago. They're searching email. The inspector waits.

Regulatory Lifecycle

The spreadsheet of lost authorizations

Product sells in 47 countries. Each registration has a renewal date. The regulatory affairs coordinator maintains a spreadsheet. Updated monthly. Usually.

Coordinator goes on maternity leave. Backup doesn't have the same system. Renewal in Thailand due in six weeks. Reminders go to coordinator's email. Nobody monitors it.

The renewal lapses. Thai registration expires. When investor due diligence asks "have you ever lost market authorization due to administrative failure," the answer is yes.

Commitments as contracts

Regulatory Commitments

Every promise to a regulatory authority is a contract. Post-marketing study by a specific date. Labeling updates within 90 days. Each has a deadline.

Seal treats commitments as first-class objects. Deadline countdown visible. Escalation as deadlines approach. Evidence of completion attached.

When the inspector asks "show me your commitment status," the answer is instant.

The variation that couldn't ship

You modified a manufacturing process. US allows implementation with annual report notification. Manufacturing makes the change. Product ships.

Six months later, you want to ship to Germany. In EU, this same change requires a Type II variation with pre-approval. You can't ship until it's approved.

Seal tracks variations globally. When a change is proposed, the system shows regulatory impact by market: which submissions needed, which require pre-approval, which can proceed immediately.

Global registration database

Every product, every market, every status. Renewal dates generate automatic reminders months in advance. When a registration approaches expiry, the system escalates until someone acts.

"Can we sell Product X in Brazil?" The answer is immediate.

Capabilities

01Submission Tracking
Track every submission from filing through approval. Documents, correspondence, questions, and outcomes in one place.
02Commitment Management
Track promises to regulators with deadlines, evidence requirements, and escalation. Never miss a commitment.
03Variation Coordination
Manage post-approval changes across multiple markets. Track classification, submission status, and implementation timing.
04Global Registration Database
Know where each product is registered, when renewals are due, and who your local representatives are.
05Renewal Tracking
Automatic reminders when registrations approach expiry. Never lose market authorization due to missed renewal.
06Regulatory Intelligence
Link external regulatory changes to your product portfolio. Know when standards updates affect your products.
07Dossier Compilation
Evidence from MES, LIMS, and QMS flows into submission modules automatically. Review and finalize, don't compile manually.
08Authority Correspondence
Track questions, responses, and follow-ups with health authorities. Institutional memory across submissions.
01 / 08
Submission Tracking
Submission Tracking

Entities

Entity
Description
Kind
Regulatory Submission
Application or notification to regulatory authority.
type
NDA/BLA
New Drug or Biologics License Application.
template
NDA-2023-ABC
NDA for Product ABC oral tablets.
instance
ANDA
Abbreviated NDA for generic drugs.
template
510(k)
Premarket notification for medical devices.
template
510(k)-2024-001
Device clearance submission filed January 2024.
instance
PMA
Premarket approval for Class III devices.
template
IND
Investigational New Drug application.
template
Regulatory Commitment
Promise made to regulatory authority with deadline.
type
COMMIT-2024-001
Post-approval stability commitment due Q4 2024.
instance
Product Registration
Market authorization for a specific product/market.
type
CE Marking
EU market authorization under MDR/IVDR.
template
REG-EU-ABC
EU CE marking for Product ABC.
instance
Health Canada
Canadian market authorization.
template
Variation
Post-approval change submission.
type
Correspondence
Communication with regulatory authority.
type
Regulatory Dossier
CTD/eCTD submission package.
type
Submission Timeline
Key dates and milestones for submission.
type
Deficiency Response
Response to regulatory questions or requests.
type

FAQ

The system supports multiple submission types—NDA, BLA, 510(k), PMA, CE marking, and others. Each pathway has its own workflow, timeline expectations, and documentation requirements. You configure which pathways apply to your products.