Use case
Active substance renewal management
Active substance renewals are the highest-stakes events in agrochemical regulatory affairs. A missed deadline or incomplete dossier can mean losing market access for an entire product line. Coveroff gives your team structured visibility across every renewal in your portfolio.
Why renewals are so hard to manage
Renewal deadlines tracked in spreadsheets
Active substance approval expiry dates, data call-in deadlines, and submission windows scattered across calendars and Excel files. Miss one and your product loses market access.
Dossier updates disconnected from obligations
New studies, updated endpoints, and regulatory responses exist in email threads and SharePoint. No clear link between what's required and what's been delivered.
Renewal impacts cascade across markets
When an active substance renewal outcome changes EU conditions of approval, every product registration in every market needs reassessment. Tracking this manually doesn't scale.
How Coveroff keeps renewals on track
Every renewal timeline, obligation, and dossier section is structured and interconnected — so your team always knows what's due, what's done, and what's at risk.
Renewal timeline management
Gantt views for every active substance renewal. See data call-in dates, submission deadlines, and approval expiry dates across your entire portfolio at a glance.
Structured dossier sections
EU Reg 283/2013 and 284/2013 templates built in. Track completion per section, assign reviewers, and identify gaps before submission windows close.
Obligation and condition tracking
Link regulatory obligations to specific studies, endpoints, and dossier sections. When conditions of approval change, see every affected product and market instantly.
Cross-market impact analysis
When an active substance renewal outcome changes MRLs or use conditions, automatically surface every product registration and market that needs updating.
Built for the AIR programme and beyond
The EU's Active Substance Review Programme (AIR) requires coordinated dossier preparation across multiple regulatory frameworks, with strict timelines and data requirements that change with each renewal cycle.
Coveroff structures every piece of this workflow — from initial data call-in response through to the final renewal decision — so your team can focus on the science, not the admin.
Never miss a renewal deadline again
See how Coveroff tracks your active substance renewals with a 30-minute demo using your portfolio. No slides, no pressure.