An Industrial Pharmacist with over 25 years of experience in CMC and quality management.

A cross-functional team consists of many disciplines.  The quality representative is often not the most favorite team member but he/she is essential for the success of any clinical development. The safety of patients should be at the heart of any Sponsor’s objective. Most of our clients work in an ‘outsourced business model’ and this means that keeping oversight on GxP activities at CROs/CMOs can be a real challenge.

Our cross-functional experts in GMP/GCP/GLP and GDP have developed a lean, flexible, and adaptable phase-appropriate ‘QMS blueprint’ tailored to ensure GxP oversight for Sponsors involved in early clinical phase development. We give our clients the flexibility to implement their QMS in a staged risk-based approach and always ensure to be pragmatic and constructive.

Our quality experts are not there to tell the team what they can or cannot do, but we strive to help teams by introducing structure to a project and we help the team by introducing and guiding them on ‘Good Documentation Practises’ from the onset of a project.

We also give training to academic partners on the meaning of GxP as this is often an ‘unknown’ territory.