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 organisations (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.
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Contact us with questions or to receive a quote.
NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020
Insights and Expertise
White Paper: Data Integrity and Warning Letters
Remote GxP Consultancy