Quality System Audits


The quality management system (QMS) is the foundation upon which everything else is built.  Without a well designed, robust and compliant QMS, no company can confidently hope to consistently provide high quality product to patients or maintain good regulatory compliance.

Our team of experienced former regulators and industry professionals can perform a thorough, in-depth assessment of your QMS against the latest regulatory requirements and industry best practices.  We will identify any weaknesses and areas for improvement and recommend solutions to address deficiencies. Our detailed audit report can then serve as the basis for a site-wide corrective action plan (CAP) to remediate deficiencies and create a more robust and sustainable QMS. NSF Pharma Biotech has extensive experience in conducting baseline audits and we have worked with numerous clients to remedy weaknesses in their QMS and create a compliant, practical and sustainable system.

For more information about NSF Pharma Biotech auditing in the U.S., email uspharma@nsf.org or call +1 202.822.1850.

For more information about NSF Pharma Biotech auditing in Europe, email pharmamail@nsf.org or call +44 1751 432 999.

Why Work With NSF?

We specialize in performing quality systems audits. Our former regulatory agency staff is skilled in performing these audits and our seasoned industry professionals have many years’ experience designing, implementing and operating robust and compliant quality management systems. Because we audit many quality systems every year, we can advise you on current industry best practice. Our staff even helped to write ICH Q10 Pharmaceutical Quality System!  No one is better placed to help you implement a compliant, workable and sustainable QMS to meet your business needs for years to come.