

Business Regularization Consulting - AFE
The initial step for a Medical Product company to perform any storage, distribution, packaging, shipping, export, manufacture, import or production activity is to regularize its situation within regulatory agencies of the various regulatory spheres - culminating in obtaining its Business Operation Authorization - AFE, from ANVISA
After the initial authorization it is also possible to request changes, such as expansion / reduction of activities, address, company name, technical responsible, legal responsible, etc.
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Know our services
Product Regularization
Internal Audit
Internal Auditor Training
Business Regularization AFE
Pre-Audit Certification
Nonconformity Treatment
Best Practice Certification
Distributor Auditing
Regulatory Affairs Training
Audit at the Suppliers
Interpretation Implementation RDC 16
Interpretation Implementation ISO 13485