Quality and Regulatory Assurance

Quality and Regulatory Assurance

The quality assurance function ensures that the API is produced according to cGMP standards, i.e. Good Manufacturing Practices.

Our quality management system is based on Standard Operating Procedures (SOPs), validations, equipment qualification, change management, deviation management, annual quality reviews, staff training and internal audits.


All our APIs are supported by DMF carefully prepared by Bioindustria LIM.

Regularly scheduled inspection visits by all major national and international pharmaceutical companies, together with their respective ministerial authorities.

Efficiency and controls applied throughout the production process, from product development to supply chain.

Experience of global regulatory “Submissions” in several countries.

Control on:

  • Analytical Methods
  • Batch Records
  • SOPs
  • Product Specifications
  • Validation Documents
Standard Operating Procedures (SOPs)

  1. Management System
  2. Analysis Laboratory
  3. Warehouses
  4. Production
  5. Maintenance
  6. Security
  7. Technical Instructions