Consulting, Auditing and Assessment

NSF International’s unique team of ex-regulatory agency inspectors and highly experienced industry professionals provide authoritative consulting and auditing services to major pharmaceutical and biopharmaceutical companies and regulatory agencies worldwide.

NSF provides in-depth, expert assessment of technical issues and help outsource your entire supplier audit programme, as well as specialist services in areas such as cost-effective quality management; manufacturing of major dosage forms, including sterile and biotech products; pharmaceutical packaging; clinical trial manufacturing; supply and good clinical practice (GCP); and pharmacovigilance (PV); as well as sterilisation procedures; pharmaceutical microbiology; supply chain assurance; good distribution practice (GDP); process and analytical method validation; regulatory compliance for computers and automated control systems; and pharmaceutical water systems.

NSF’s pharma biotech can help you with:

• Preparing for regulatory inspections
• Due diligence audits for acquisitions
• QS audits
• Mock regulatory inspections
• Good manufacturing practice (GMP) compliance audits
• Good laboratory practice (GLP), GCP, PV, clinical laboratory improvement amendments (CLIA) and Biotechnology monitoring program (BIMO) audits
• Over-the-counter (OTC) current good manufacturing practices (cGMP) audits