Global Pharma QA customizes our audits/consultancy according to your specific needs. Audit plans are developed using a risk based approach that ensure regulatory compliance.

For-cause audits are conducted if there are any concerns regarding possible fraud or possible misconduct or client complain. It is often preferable that an independent auditor conducts these audits, as it promotes impartiality.

 

We offer the GLP/GCLP/Good Practice Audits Qualification Assessment audits of CROs and other Vendors
Independent audits of CROs prior to contract placement to provide or as a routine vendor control, assurance that the organization is fully compliant with relevant regulation and is able to provide the service required:

  • Animal Facility Audits  and critical in-life study procedures and Pre-clinical Laboratories Audits analyzing your non-clinical samples (e.g. biochemistry, bioassay, histology, archive) to assure compliance with GLP.

  • Clinical Laboratories Audits – GCLP/ISO15189/WHO analyzing your clinical samples to assure compliance with Good Clinical Laboratory Practice.

  • Non-Regulated / University Labs – Good Practice
    Review non-regulated / university labs laboratories analyzing your samples to assure compliance with good practice and reliability of study data.

  • Reports Audit and Regulatory Submissions Audit: NDA, IB, IND, Response letters
    To provide assurance that the no-clinical/clinical analysis study report accurately reports the conduct and results of the study and that the format complies with GLP.
     QA Review of GLP/GCLP sections of regulatory submissions. 

We can use Global Pharma QA platform or your SOPs and computerised systems to meet your needs.

We can help you develop and deliver a complete a Risk Based Yearly Audit Program for nonclinical studies and clinical analysis or help with particular Quality System aspects, as needed.

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