Consultancy and services in the areas subject to the Sanitary Surveillance regime regarding human products, pharmaceuticals, food, beverages, cosmetics, hygiene products, veterinary products, health products, sanitizers, perfumes, supplements and all of its inputs including reagents supporting all activities from the manufacturing, import, storage, distribution and marketing of products and their respective inputs, Productions Authorization and Special Authorization.
Our
Services
Authorization of Operation of Company (AFE) - ANVISA
Law nº 6.360/76, Decree nº 79.094/77 Law nº 9.782/99 Decree nº 3.029/99 for the operation of companies that intend to carry out activities of Extracting, Producing, Manufacturing, Transforming, Synthesizing, Packaging, Repackaging, Importing, Exporting, Storage, Dispatching, Distribution, contained in Law 6.360/76, Decree 79.094/77 and Law nº 9.782/99, Decree nº 3.029/99, correlated to Medicines, Drugs and Pharmaceutical Supplies is required the Authorization of ANVISA, an organ linked to the Ministry of Health.
In this sense we have a wide experience in the preparation of companies and in the elaboration of documentation to subsidize the obtaining of Authorization of Operation of Companies as well as their extensions of activities and classes.
The Special Authorization (AE) to be obtained for the activities of Storage, Distribution, Packaging, Dispatch, Export, Extraction, Manufacture, Fractionation, Import, Production, Purification, Repackaging, Synthesis, Transformation and Transportation of Pharmaceutical products and pharmaceutical inputs intended for use human being is conditioned to the granting of AFE, that s, only company with AFE can request AE.
In this sense we have a wide experience in the preparation of companies and I the celebration of documentation to subsidize the obtaining of Special Authorization as well as their extensions of activities and classes.
Special Authorization (AE) - ANVISA
Production Outsourcing and Quality Control Contract
It has a group of specialists in the elaboration, revision, submission of contracts of outsourcing of stages of production, analysis of quality control and storage of medicines.
Quality auditing is a management tool used to evaluate quality actions foreseen in a quality system. It’s a constructive process and helps to prevent problems.
Audit of the Quality System
Pre - Inspection (Mock)
The pre-inspection (mock) is carried out in the national or international manufacturers of medicines that need to be in compliance with the respective Brazilian Legislation to subsequently receive the sanitary inspection performed by ANVISA.
The main objetive is evaluate in detail the quality system of the company against the Brazilian legislation, through the evaluation of the manufacturing areas in the production of APIs and finished products (starting with receipt of the raw materials until the product is shipped in the end concept to to end), going through the rigid and careful evaluation of every Quality Management System.
Through the evaluation of the different topics such as: Master Site File, Drug Master File, Floor Plans, Flow Chart, Organization, Procedures, Qualifications (equipment, areas, utensils, Project), CAPA - Implementation Corrective and Preventive Action System; Risk management; Validations of Computerized Systems, APR - Annual Product Review, Validation of Analytical Methods; Validation of Microbiological Methods; Process Validation; Cleaning Validation; Stability and photo stability studies; Change Control; Auto Inspection, PCMSO, PPRA etc.
- The companion of the official inspection:
The official inspection follow-up is part of the scope if so desired by the contracting company. The objective of this work is to provide the necessary support during the inspection in order to mitigate risks that may lead to the rejection of the Certification of Good Practices, which generates costs and wear and tear on the company.
- Elaboration of Records, registrations or notifications of products sanitarily regulated as; medicines and active pharmaceutical ingredients;
- Specialized technical support for the preparation of responses to ANVISA’s requirements for registration and revalidation of sanitary regulated products.
- Product Change History - HMP and Change Control.
Drugs Registration / Registry Transfer
Support in Projects Industries and Regulatory Affairs
We have ample knowledge (knowhow ) for the preparation, follow-up of industrial projects as well as strategic vision in terms of Regulatory Affairs always updated to offer our clients competitive technical conditions for short, medium and long term project.
