PO Box 6255

Thrapston, Kettering Northants NN14 4ZL

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t:   +44 (0) 1234 783466

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e:   info@qualogy.co.uk

GLP audit and consultancy services range from the conduct of individual audits to the management and execution of a GLP QA programme, and include:

• High level assistance with assessment of, and improvement to, existing GLP systems to enhance the business need in addition to compliance.

• Preparation for GLP Inspections - in preparing for a regulatory inspection we can undertake a "mock" Regulatory Authority GLP inspection.

• In-house GLP Auditing - all aspects of auditing can be undertaken.

• CRO Audits - facilities and/or studies; pre-placment assmenst, in life inspections and review of study reports.

• Computer Systems Compliance - validation and compliance with FDA 21CFR Part 11.

• Independent QA function - to perform the role of QA or just to cover periods of high workload.

• Assisting companies to implement GLP from start right through to inspection by a Regulatory Authority.

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