The renewal that nobody remembered.

Marketing authorization in Brazil expired. Nobody noticed until a distributor couldn't import. The renewal application should have been filed six months earlier. Now there's a gap—product can't be sold, patients can't get medicine, and re-registration will take eighteen months. One spreadsheet. One missed update. One country out of sixty-three where the product is registered. The cost: $4 million in lost revenue and a regulatory relationship that will take years to rebuild.

This is what happens when regulatory lifecycle management depends on someone remembering. Registrations aren't one-time events. Renewals, periodic reports, commitment fulfillments, license maintenance fees—each market has requirements that recur on different schedules. Nobody can track sixty-three markets in a spreadsheet without something slipping through.

Complete registration portfolio

How many markets is Product X registered in? When does the Thailand registration expire? What variations are pending in the EU? Which markets still need the latest labeling update? Seal maintains your complete registration portfolio—every product, every market, every status—so these answers are immediate rather than requiring spreadsheet archaeology or checking with local affiliates.

The lifecycle tracks automatically. Five-year renewal coming up in Mexico? Task created eighteen months out. Annual report due in Japan? Reminder generated. Pharmacovigilance agreement expiring? Flag raised. The system knows what's coming and nobody needs to remember.

When operational changes happen, regulatory impact maps automatically. A manufacturing process changes—which markets require notification? Which require prior approval? When change control approves the change, affected registrations identify themselves, regulatory affairs sees what submissions are needed, and tracking continues through completion.

Labeling, dossiers, and correspondence

Product labeling varies by market: different languages, different required statements, different formats. When core labeling changes, Seal identifies which market-specific labels need updating and tracks artwork versions linked to the registrations they support. The EU requires one set of statements, Brazil requires another, and the system knows which is which.

The registration dossier is the master regulatory file—Module 1 varies by region while Modules 2-5 are ICH common. As the product evolves, the dossier evolves. Current approved content, pending variations, historical versions—when you need to know what you submitted in the original NDA, the answer is there rather than in an archive box someone has to locate.

Agency correspondence accumulates over years. Regulators ask questions, you respond, they follow up. Seal maintains every question and response indexed by product and market. When preparing a new submission, see what you've previously told this agency about this topic. Consistency matters—regulators notice when your story changes.

Commitments and conditions

Approval often comes with strings attached. Post-marketing commitments, risk evaluation and mitigation strategies, pediatric study requirements, post-authorization safety studies. Miss a commitment deadline and you've created a compliance issue with the agency that approved your product.

Seal tracks commitments from the moment they're imposed. Milestone dates, deliverables, responsible parties—all visible. As deadlines approach, tasks generate. When commitments complete, evidence links to the record. The FDA asks about your REMS milestones? The status is current, not reconstructed from email threads.

Global coordination and intelligence

You add a manufacturing site. Sixty-three markets need to know—but each has different requirements. The US wants a CBE-30 supplement. The EU needs a Type II variation. Japan accepts notification. Brazil requires prior approval. Canada wants a Level II change. And so on, sixty-three times.

Without a system, you're managing sixty-three spreadsheets, hoping someone remembers Korea's requirements differ from Taiwan's.

Seal maps the change to market-specific requirements automatically. Define the global change once. The system identifies every affected registration, determines what each market requires, generates the submission tasks, and tracks progress. Regional teams see what's coming from global. Global sees what's completing locally. Nothing slips through because nothing depends on someone remembering.

Regulations change constantly—new guidance, evolving requirements, enforcement trends. A new stability requirement in Japan flags for products registered there. EU pediatric requirements changing link to affected products. You see what's changing and assess impact proactively rather than discovering it when someone asks why you're not compliant.

Market authorization holders and agents

In many markets, a local entity holds the registration. Marketing authorization holders, local agents, distributors with regulatory obligations. Seal tracks who holds what, where, with agreement terms and renewal dates. When an agent agreement expires, you know before the registration lapses.

Site registrations matter too. Manufacturing sites need authorization in many markets. When you add a new manufacturing site, Seal identifies which registrations need updating. When a CMO relationship ends, you know which registrations are affected before supply chain disruption.