Pharma and Biotech Industry Audit Services
NSF experts include former regulators who perform audits and mock inspections across the product lifecycle. Our team also audits suppliers and service providers to the pharmaceutical industry.
Quality Systems Audits (PQS)
The quality system (QS) ensures that your company operates in a compliant manner. NSF performs on-site audits across the globe, as well as remote audits. We identify gaps in your QS and can provide pragmatic solutions for closing them.
Supplier and Contractor Audits
Our quality risk management approach helps you define which third-party companies or contract manufacturing organizations (CMOs) to audit on-site or assess remotely. In addition, we provide global auditing services for material suppliers, including CMOs manufacturing all pharmaceutical dosage forms, excipients and active pharmaceutical ingredients (APIs).
Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice, Pharmacovigilance and Good Distribution Practice regulations apply across the supply chain. Our experts perform audits in each of these disciplines to global regulatory standards, including EMA, U.S. FDA, WHO, PIC/S and ANVISA.
Due Diligence for Acquisitions
Use NSF's independent, experienced team of auditors to determine whether your company's future acquisitions are sound or require remediation. Our team's findings help company stakeholders perform due diligence and make critical decisions about the acquisition process.
Ready to Begin the Process?
Contact us with questions or to receive a quote.
Pharmaceutical Remote Audit Process
Webinar: An Update on Remote and Virtual Auditing
Webinar: Remote and Virtual GMP Audits
News and Events
NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training
May 19, 2020
To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.
NSF’s Health Sciences Team Joins Fight to Save Lives With More Ventilators
April 23, 2020
NSF’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.
NSF Experts Deemed Eligible To Act As MHRA Compliance Monitors
September 12, 2022
Annex 1 Revision, FDA Biosimilar Workshop & More – September Update
September 1, 2022