We offer audits for high quality GxP requirements, in which we assess the level of compliance and implementation of the quality systems for customers and/or suppliers and outsourced activities.
Good Manufacturing Practices
- Supplier audits: Manufacturers of APIs, 1st and 2nd packaging material, excipients, intermediate product, finished product.
- Audits for manufacturing laboratories (CMO).
- Audits for testing laboratories (quality control)
Good Distribution Practices
Audits for logistics operators (warehouses, distribution centres and carriers):
- API Distributor
- Excipient distributor
- Intermediate product or finished product distributor
- Intermediate warehouses
Good Clinical Practices
Audits for CRO, promoter of clinical trials.
Good Laboratory Practices
Audits for preclinical development laboratories, focused on research.
Good Pharmacovigilance Practices
- Internal audits of Pharmacovigilance Systems
- Support and assistance in inspections issued by the health authorities
- External audits of subsidiaries, partners and CROs
- In-person/remote audits