Mike Regan

Creating post market survaillence reports in accordance with Novartis procedures.

Remediation of CAPAs created due to audit findings raised in preparation for an FDA audit

Provision of consultancy services for integrated commissioning and qualification of a new Recombinent Facility for the production of blood factors VII / VIII and XIV for the treatment of haemophilia.

To assist supplier companies in validation of critical processes

Validation of an aseptic filling line for production of clinical trial materials

Legacy review of process monitoring and remediation of Process Validation descrepancies.

Assisting a first tier logistics supplier in becoming the GDP supplier for a major pharmaceutical company wishing to out-source distribution for DACH countries.

Review of quality documentation for technical transfer of a process from Austria to Switzerland

Technical support for product improvement of a aerogel based phosphorescent screen

Chemistry Environmental studies