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.


  • Sub-contract testing laboratories
  • Sub-contact sterilisation facilities

Contact us for more details