Case studies — GMP consulting and regulatory consulting results
Cytomos Ltd — QA & regulatory built from scratch
- Designed and implemented a complete QA and regulatory function for Cytomos, an Edinburgh MedTech startup
- Selected, qualified and implemented an eQMS.
- ISO 9001 certification achieved in 13 months with zero non-conformances.
- Set and implemented the regulatory strategy for the company, and prepared the Technical File for CE/UKCA certification for the novel analytical instrumentation.
Site QMS Remediation
- On several occasions, I’ve been hired to remediate failing Quality Management Systems, often with significant Regulatory Inspections upcoming, which threaten the viability of the Site
- In all cases, the focused, detailed and pragmatic project management approach taken resulted in the QMS being improved and restored to orderly function such that the feared Regulatory Inspection passed without too much stress
AstraZeneca — diverse successful project roles
- Project managed the creation of a new Global Marketing Company Operational Quality function within AstraZeneca, on time and in budget.
- Developed and delivered a global vaccine change control management system across AZ and CMO networks to enable swift release of lifesaving medicine during the Covid pandemic
- Harmonised and simplified Alexion and AZ QA processes for rare disease product registration and distribution during Alexion integration into AZ.
‘Gavin made an exceptional and lasting contribution to the company during his time with us.’
Nick Smith, Chief Technology Officer, Cytomos Ltd
