Services:

Preparation for UK Government Inspection

Scilla Cullen can bring a wealth of experience to bear on the assessment of your facility's GLP status. She understands the standards required for maintenance of GLP compliance in the eyes of the UK GLP Monitoring Authority. She is familiar with their interpretation of the GLP principles and as a Senior GLP Inspector was instrumental is setting those standards and interpretations.

Together with her former colleague, she has tutored and monitored the two newest MHRA GLP Inspectors.

Implementation of GLP

Scilla has inspected many facilities that were in the process of implementing GLP. She can advise on the fundamental standard expected by the Monitoring Authority. She has insight into how to avoid common mistakes and can instruct staff how to work to GLP. The secret of success is not to make life too complicated!

Study Audits

Non-routine "for cause" study audits. If you have a problem with a study and you cannot tell whether it is a GLP problem or not and you want an independent internal audit Scilla will be pleased to perform that function.