In Pharmaceutical manufacture, compliance with Good Manufacturing Practice is critical, and regular audits of procedures and practices can help to ensure that major product quality and Regulatory compliance issues are avoided.

In the emerging area of drug-device combination products, critical assessments of approaches to managing GMPs and Quality System issues can prevent problems from occurring in the field and provide increased confidence to third party assessors that key control factors have been identified and are being managed.

We have experience of working in these areas in Europe, USA and Asia-Pacific.