01 — SEGMENT
PharmaceuticalSegmentComplete.
Complete expertise in drugs, pharmaceutical inputs and medical gases. From initial registration to renewals with ANVISA.
Reach
Solutions for the segment
Deep knowledge of ANVISA regulations for pharmaceutical products.
Drug Registration
Complete registration process with ANVISA.
- New drugs
- Generics and similars
- Biologics and specifics
Post-Registration
Management of changes and registration maintenance.
- Formulation changes
- Presentation additions
- Periodic renewals
Pharmaceutical Inputs
Regularization of APIs and excipients.
- API registration
- Brazilian DMF
- Supplier certification
Medical Gases
Licensing and registration of gases for medical use.
- Medical oxygen
- Nitrous oxide
- Medical compressed air
Pharmacovigilance
Implementation of post-marketing surveillance systems.
- PSUR/PBRER
- Event notification
- Recall management
Clinical Studies
Regulatory support for clinical research.
- Investigator dossier
- CEP/CONEP interface
- Product import
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.
Services for this segment
Need pharmaceutical support?
Our specialized team is ready to manage your regulatory processes.