07 — SEGMENT
Regulated Logistics Operations.
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.