Quality Management & Regulatory Compliance (QMRC)

A pharmaceutical company were looking to move to disposable systems and change their primary packaging.

CASE STUDY 1

SITUATION
Pharmaceutical operations remediation to restore licence to manufacture from the regulatory inspectors.
SERVICE
Operations management.
RESULT
The remediation team working to deliver operations and engineering systems remediation from an operations perspective as part of a Quality Management programme to pass an inspection to regain a manufacturing licence.

CASE STUDY 2

SITUATION
A pharmaceutical company looking to move to disposable systems and change the primary packaging.
SERVICE
Project management of feasibility studies.
RESULT
The feasibility studies collated operational information, timelines, impacts and costs which allowed the management to decide on the acceptability of the projects.