Good Laboratory Practice (GLP) ensures the accuracy, validity, reliability, and integrity of study data submitted to regulatory authorities.
Pharmatek’s team of experienced GLP experts offers comprehensive auditing services worldwide. Our capabilities include pre-study site qualification, facility inspections, process analysis, study data and report review, data archival, and specialized services. Our audits adhere to FDA and EU regulations (21 CFR Part 58, OECD), providing a rigorous framework for assessing compliance.
With expertise in auditing central and bio-analytical laboratories, we collaborate closely with your team to tailor audits to your specific needs. Our experts will create a customized audit plan and conduct a thorough assessment, identifying areas for improvement and providing recommendations for remediation.
Our commitment to client satisfaction drives our approach. We maintain open communication, conduct regular site visits, and promptly report critical findings to ensure timely resolution of any issues.
We’re ready to collaborate and support your needs. Reach out to start the conversation!
Pharmatek Solutions Inc. is an integrated Validations, Clinical, and Quality business solutions provider to global life sciences companies.