07 — SERVICE
CompletePost-RegistrationActivities.
Changes, additions, renewals and registration maintenance. Follow-up on technical requirements and regulatory adjustments.
Scope
Post-registration services.
Complete management of your products' regulatory lifecycle.
Registration Changes
Filing of changes with ANVISA.
- Major changes
- Minor changes
- Change notifications
Renewals
Registration renewal before expiration.
- Advance planning
- Dossier updates
- Deadline compliance
Additions
Addition of new presentations, indications or manufacturers.
- New presentations
- New manufacturers
- Line extension
Cancellations
Management of voluntary cancellations and discontinuation.
- Voluntary cancellation
- Discontinuation plan
- Authority communication
Technical Requirements
Response to requirements and commitment fulfillment.
- Requirements analysis
- Response preparation
- Technical negotiation
Monitoring
Continuous tracking of deadlines and obligations.
- Expiration alerts
- Petition status
- Periodic reports
How we work
A clear path, from diagnosis to approval.
The same method in every project: understand the product, chart the route and steer the process to a decision — with visibility at every step.
Diagnosis
Deep dive into the product, the operation and the applicable regulatory framework.
Strategy
Route definition: requirements, documentation, deadlines and owners.
Execution
Dossier preparation, filing and dialogue with the regulatory authority.
Approval and maintenance
Follow-through to the decision and post-approval management to keep everything valid.
Segments served
Keep your registrations current
Proactive management to avoid registration losses and maintain continuous compliance.