07 — SEGMENT
RegulatedLogisticsOperations.
Storage and distribution of regulated products. Licensing, permits and good distribution practices.
Reach
Solutions for logistics operations
Expertise in licensing and compliance for storage and distribution.
AFE - Operating Authorization
Licensing with ANVISA.
- Distributors
- Warehouses
- Transporters
Special Authorization
AE for controlled products.
- Psychotropics
- Narcotics
- Chemical precursors
CBPD
Good Distribution Practice Certificate.
- Gap analysis
- Inspection preparation
- Adequacy plan
Cold Chain
Qualification for temperature-sensitive products.
- Thermal mapping
- Equipment qualification
- Transport validation
Traceability
National Drug Control System.
- SNCM/IUM
- Serialization
- System integration
Logistics Operator
Outsourcing of storage and distribution.
- Outsourcing contract
- Technical responsibility
- Periodic audits
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
Logistics operation to license?
From AFE to GDP certification, we manage the entire process.