We can also provide auditing services in the following areas designed to meet your specific requirements.
Sub-Contract Auditing
- We can supplement your internal quality auditing programme by conducting routine audits with your own personnel to enhance objectivity and criticality of the audit process.
EU Regulations
- MDD 93/42/EEC & ISO 13485:2016 (EU)
Drug Product GMP's
- Finished Pharmaceuticals 21 CFR Part 211 (US)
- EU Directive 2003/94/EC & Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice (EU)
Good Laboratory Practice
- 21 CFR Part 58 Good Laboratory Practice For Nonclinical Laboratory Studies (US)
- ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.
Suppliers
- Sub-contract testing laboratories
- Sub-contact sterilisation facilities