PSC Biotech^® is your trusted partner for auditing services, bringing over 25 years of experience supporting leading life science companies in meeting FDA, EMA, and global regulatory requirements. Our seasoned auditors offer deep expertise in internal and supplier audits, CAPA remediation, risk assessments, regulatory compliance, and Quality Management System (QMS) implementation. With a proven track record of 100+ successful audits across pharmaceuticals, medical devices, and combination products, we ensure your processes are efficient, compliant, and inspection-ready.

Internal Auditing & Supplier Audits | CAPA Remediation & Risk Assessments | Regulatory Compliance for Life Sciences | Quality Management (QMS) Implementation 

PSC Biotech^® specializes in compliance audits across multiple regulatory frameworks, including:

• FDA 210/211
• ISO 45001
• EU Guidance
• Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP)
• Good Automated Manufacturing Practice (GAMP)
• ICH Q7 & Q10 Compliance
• FSMA, AS9100, IATF 16949
• ISO 9001 Quality Audits
• Good Manufacturing Practices (GMP) Audits
• Risk Assessment Audits
• Regulatory Compliance Audits

As regulations continue to evolve, PSC Biotech^® ensures your company stays ahead. Let us help you manage compliance challenges efficiently and cost-effectively.