Quality and Regulatory Affairs

Quality Assurance ensures systematic compliance to established procedures. The use of KPIs and quality tools allow the application of preventive and corrective measures, as well as the effective management of the company’s quality management system.

Regulatory compliance guarantees the sale of products, which is why we work in an integrated manner with our customers to ensure compliance with standards and correct registration submission.

Our services in Quality and Regulatory Affairs include:

• Good Practices Implementation
• Statistical Tools
• Quality Management Systems, QRM
• Standard Operational Procedures, SOP
• Periodic Product Review, PPR/ APR
• Supplier Qualification
• Tech Transfer
• Audits Internal and External
• Management of:
  • Changes
  • Complaints 
  • Risk 
  • Deviation, CAPA