Services Offered

Specialized internal audit and compliance services designed to strengthen your Quality Management System (QMS), ensure ongoing regulatory readiness, and support continuous improvement across life science operations.

Internal Audit Services

• FDA Regulatory Audits – Comprehensive internal audits and gap assessments aligned to:
  • 21 CFR Part 11 – Electronic Records and Signatures
  • 21 CFR Parts 210 / 211 – Drug GMP Requirements
  • 21 CFR Part 820 – Quality System Regulation (Medical Devices)
  • 21 CFR Part 1271 – Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
• ISO Quality Management System Audits – End-to-end internal auditing against international standards:
  • ISO 9001:2015 – Quality Management Systems
  • ISO 13485:2016 – Medical Device QMS Requirements
  • ISO 17025:2017 – Testing and Calibration Laboratories
• Supplier & Vendor Audits – Evaluation of external partners for compliance, risk management, and alignment with QMS expectations.
• Pre‑Inspection Readiness – Preparation and mock audits for FDA, ISO, and third-party assessments.
• CAPA Review & Effectiveness Checks – Verification of corrective and preventive actions to ensure sustainable compliance.

Each audit engagement includes a detailed assessment report, objective evidence of findings, and actionable recommendations to drive measurable quality improvement and regulatory assurance.