06 — SERVICE
ProductRegistrationServices.
Registration, notification and product filing with ANVISA. Complete technical dossier preparation and follow-up until approval.
Modalities
Types of registration.
Expertise in all registration modalities with ANVISA.
Product Registration
Complete registration process for products requiring prior approval.
- Medicines
- Health products
- Special foods
Notification
Registration of low-risk products by notification.
- Grade 1 cosmetics
- Risk 1 sanitizers
- Exempt foods
Filing
Product filing in simplified modality.
- Medical devices
- Equivalent products
- Simplified filing
Technical Dossier
Complete dossier preparation according to current regulations.
- CTD/eCTD
- Stability studies
- Technical specifications
Follow-up
Monitoring and response to ANVISA technical requirements.
- Petition protocol
- Response to requirements
- Administrative appeals
Import
Registration of imported products and manufacturer interface.
- Import dossiers
- Certificates of origin
- External good practices
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
Register your product
From technical dossier to final approval, we manage the entire registration process.