Company
Good Manufacturing Practices (GMP) certification
We prepare and conduct Good Manufacturing Practices (GMP) certification — for makers of medical products outside Mercosur and of sanitizing products — from document review to submission and follow-up in the DOU.
What we deliver
- Guidance and review of the documentation for GMP certification
- Preparation of documentation for the Anvisa system
- Submission in Solicita and fee issuance
- Follow-up of the filing and the petition until the DOU
Who it's for
International manufacturers (except Mercosur) and sanitizing-product makers seeking or renewing GMP certification.
Documents we usually request
- Quality system documentation
- Data and layout of the manufacturing facilities
- Inspection history, when available
Not included
- Anvisa fee
- Pre-audit (on-site, remote or documentary) and accompaniment of the Anvisa audit
- Translation beyond English and Spanish