Service 01
Regulatory framework
Classification of activities and necessary authorizations.
Specialized consulting • Industry & Commerce • Logistics
Technical Consulting and Advice for Transportation and Logistics
Logistics compliance needs to survive the journey, not just the warehouse. In sanitary logistics, quality changes hands without ceasing to be responsibility. The consultancy maps transfer points: receipt, quarantine/release, storage, separation, shipping, transportation, return and collection. For medicines and other sensitive products, temperature criteria, qualification and documentation need to follow the applicable specific standards.
This advice is indicated for: companies, entrepreneurs, technicians and managers seeking sanitary licensing, documentary adequacy or regularization for transport and logistics, according to the competence of the Health Surveillance, Anvisa or other applicable body.
5+technical fronts
5base deliverables
8Eight Doubts Answered
Qualified end-to-end route
sanitary logisticstransporte medicamentocadeia friaAFE
Technical services
How PITRIO can work in Transportation and Logistics
The scope is defined from the business stage. Hiring can begin with diagnosis and framing and evolve to documentation, adequacy, implementation, training, protocol and technical monitoring.
Service 02
Regulatory design
Stock zoning by conservation status and condition.
Service 03
Temperature and process
Temperature/humidity monitoring where applicable.
Service 04
Auditable documentation
Qualification of packaging, routes and carriers according to risk.
Service 05
Follow-up and evidence
Procedures for return, damage, theft, excursion and collection.
Exclusive technical panel
Qualified end-to-end route
A visual object created to represent the points you need to talk about in a transportation and logistics consultancy: risk, process, evidence and decision.
Qualified end-to-end route
RiscoTechnician Diagonosis
Released product mixed with quarantine.
ProcessoRegulatory design
Stock zoning by conservation status and condition.
EvidenceSanitary flows and design
Logistics flow map.
DecisionAuditable documentation
Simulation of excursion/collection.
Quando contratar
When the consultancy avoids expensive rework
The objective is to anticipate technical, documentary and regulatory incompatibilities before they become a requirement, redone work, stopped batch or protocol delay.
SINAL 01You are opening, enlarging, changing address or regularizing a transport and logistics operation.
SINAL 02It has already received a requirement, inspection term or note related to released product mixed with quarantine.
SINAL 03Existing documents no longer reflect the operation, especially in logger without reading and response procedure.
SINAL 04You need to organize a logistics flow map before investing, filing or receiving inspection.
SINAL 05You want to reduce rework and have a defined technical route before hiring work, buying equipment or changing product.
PITRIO method
Four technical decisions to move forward with less uncertainty
The schedule is adjusted to the dependencies of the client, the project and the competent body. Each phase needs to produce a decision, document, adequacy or verifiable evidence.
01
Diagnostic
End-to-end map of the chain.
02
• Technical architecture
Routes and storage risk analysis.
03
Implantation
Structuring of procedures and records.
04
Validation and support
Simulation of excursion/collection.
Regulatory basis
Official sources and applicable competence
Sanitary licensing is carried out within the scope of the National Health Surveillance System and may be conducted by the municipal or state authority, according to local organization, activity and risk. Regularization of the establishment and regularization of the product are different fronts.
ANVISA — National Health Surveillance System (SNVS)
Official reference used to validate competence, concept or requirement. In the project, the current version and the complementary acts are checked according to the specific case.
ANVISA — Operating Authorization (AFE/AE)
Official reference used to validate competence, concept or requirement. In the project, the current version and the complementary acts are checked according to the specific case.
Responsibility Notes pITRIO provides consulting and technical advice. Registration, license, certification, equivalence, authorization or approval are acts of the competent authority and depend on full compliance with the applicable requirements.
Deliverable
What you get to move forward safely
The final list depends on the contracted scope and the stage of the business. The goal is for each delivery to have a practical function: guide the team, support the protocol, respond to the requirement, register control or demonstrate compliance.
Sanitary flows and design
Logistics flow map.
Temperature and process
Temperature excursion procedure.
Regulatory design
Checklist of carriers.
OPERATIONAL DEPLOYMENT
Route qualification matrix.
Traceability and evidence
Traceability and recall plan.
Understand before filing
Establishment license, product regularization and sanitary routine: what changes in transportation and logistics
Sanitary licensing is carried out within the scope of the National Health Surveillance System and may be conducted by the municipal or state authority, according to local organization, activity and risk. Regularization of the establishment and regularization of the product are different fronts.
What belongs to the store?
Sanitary licensing, structure, flows, technical responsible when applicable, procedures and operational conditions are evaluated according to the activity and the local authority.
What belongs to the product?
When there is a product subject to regularization, the consultancy separates product requirements, labeling, composition, dossier and communication/registration applicable to transport and logistics.
What needs to work on a day-to-day basis?
Good practices, SOPs, records, traceability, cleaning, supplier control, waste, storage and response to deviations need to be executable and demonstrable.
Technician Diagonosis
Issues separating a consistent process from a fragile protocol
The analysis confronts applicable requirement, project, documents, actual routine, records and business objective. The focus is on identifying cause and priority, not just listing to-dos.
OPERATIONAL DEPLOYMENT
Released product mixed with quarantine.
Auditable documentation
Logger without read and answer procedure.
Dossier and documentation
Third-party carrier without qualification/documentation.
Technician Diagonosis
Return reinstated to stock without evaluation.
Perguntas frequentes
FAQ — Important Transport and Logistics Questions
We gather answers to questions that usually appear before hiring a consultancy, initiating adjustments, filing documents or receiving an inspection.
Does every carrier need AFE?
The need depends on the type of product and activity. Framing must be done before requesting authorizations.
In-vehicle thermometer solves cold chain?
No. It is necessary to define range, positioning, recording, calibration, analysis and response to deviations.
Does outsourcing transportation transfer all responsibility?
No. The contractor needs to qualify and control the service in accordance with the applicable obligations.
How to obtain or renew sanitary regularization for transportation and logistics?
The starting point is a diagnosis of the current transport and logistics stage: activity, location, products/services, facilities, existing documents and business purpose. From this, PITRIO defines the regulatory route, the pending issues and the work sequence without promising a rite that depends on the competent authority.
Does the company need a local license, AFE/AE or product regularization?
The need depends on the framework. In the diagnosis, we evaluated records/licenses, design or layout, memorials, procedures, controls, labels, evidence and documents of the technician in charge. The final list is specific to transportation and logistics and to the competent body.
What documents, SOPs, manuals and projects should be prepared?
Sanitary licensing is carried out within the scope of the National Health Surveillance System and may be conducted by the municipal or state authority, according to local organization, activity and risk. Regularization of the establishment and regularization of the product are different fronts.
How to prepare for a Health Surveillance inspection?
The strategy depends on the applicable process. In some cases the design and documents precede the final work; in others, the authority requires verifiable conditions in the establishment. The consultancy organizes this sequence to reduce rework.
Does the consultancy meet requirements and help in the adequacy of the operation?
Yes, when hired in scope. Follow-up may include protocol, organization of evidence, analysis of requirements, preparation of responses, review of documents, and technical support for adjustments. The final decision, official deadlines and inspection remain the responsibility of the public agency.
Turn your transportation and logistics demand into a clear technical plan
Send city/State, activity, products or services, current situation, existing documents and business purpose. Based on this information, we can delimit the problem, identify the regulatory route and propose a consulting scope compatible with the stage of your business.