08 — SERVICE
GMPCertificationsand More.
Good Manufacturing Practice certification, preparation for ANVISA inspections and compliance with ISO standards and specific certifications.
Credentials
Our certifications.
Complete preparation for obtaining and maintaining certifications.
ANVISA CBPF
Good Manufacturing Practice Certificate issued by ANVISA.
- Medicines
- Pharmaceutical inputs
- Health products
International GMP
Preparation for international agency inspections.
- FDA (USA)
- EMA (Europe)
- PMDA (Japan)
ISO 13485
Management system certification for medical devices.
- QMS implementation
- Audit preparation
- Certification maintenance
ISO 9001
Quality management system for general processes.
- Gap analysis
- Implementation
- Internal audits
Inspection Preparation
Adequation and training to receive regulatory inspections.
- Compliance checklist
- Mock inspections
- Team training
Maintenance
Continuous management to maintain valid certifications.
- Follow-up audits
- Renewals
- Continuous improvement
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.
Segments served
Obtain your certification
From preparation to approval, we ensure your company meets the highest quality standards.