Through its long experience working with clients from around the world Qualogy has an unsurpassed expertise in assisting organisations improve the quality systems implemented for compliance with the global GxP regulations.
Qualogy provides through its consultancy service guidance and expertise in the implementation and operation with Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP).
We offer consultancy services to assist and ensure compliance with the regulations and the implementation of robust quality systems.
GLP Good Laboratory Practice Consultancy Services
GLP audit and consultancy services range from the conduct of individual audits to the management and execution of a GLP QA program, and include:
- High level assistance with assessment of, and improvement to, existing GLP systems to enhance the business performance in addition to compliance.
- Preparation for GLP Inspections – in preparing for a regulatory inspection we can undertake a “mock” Regulatory Authority GLP inspection and provide guidance in the preparation of such inspections.
- In-house GLP Auditing – all aspects of auditing can be undertaken.
- CRO Audits – facilities and/or studies; pre-placement assessments, in life inspections and review of study reports.
- Assisting companies to implement GLP quality systems from the start right through to inspection by a Regulatory Authority.
GCP Good Clinical Practice Consultancy Services
- Investigator site audits
- Phase 1 facility audits
- Trial Master File audits
- CRO’s, SMO’s, Subcontractors
- Clinical Laboratories – for adherence to Good Clinical Laboratory Practice (GCLP)
- Archiving of Investigator Files and Trial Master Files