Existing authorization audit
Review of certificate, uses, label, sources, specifications and previous commitments.
- Authorized scope
- Modification history
- Still-valid documents
Regulatory lifecycle
Renewal requires an early review of the existing authorization, changes since approval and evidence that may need updating before the applicable deadline.

Review of certificate, uses, label, sources, specifications and previous commitments.
Identification of new evidence, conclusions or requirements that may affect the product or active substance.
Assessment of manufacturer, source, composition, rate, use, PHI, packaging or ownership changes.
Backward planning and preparation of a consolidated, quality-controlled renewal package.
Working method
Each stage produces a clear output and a documented decision point.
Regulatory requirements may change. Before any submission, the applicable texts, authority procedure and project-specific evidence requirements are checked.
Related expertise