Ensuring Regulatory Compliance Across the Product Lifecycle
GxP (Good Practice) principles—GMP (Manufacturing), GLP (Laboratory), and GCP (Clinical)—form the global compliance backbone for life sciences. BQCIS provides independent audits ensuring your operations meet regulatory expectations and remain inspection-ready.
Our certified auditors evaluate your Quality Management System (QMS) for conformity with FDA, EMA, WHO, and ISO 13485 standards. We help clients proactively identify weaknesses, remediate non-conformances, and strengthen QMS maturity to avoid costly regulatory findings.
From Pre-Approval Inspections (PAI) readiness to CAPA system improvement, BQCIS transforms compliance management into a strategic advantage—enhancing data integrity, risk control, and quality culture.
Key GxP Auditing & QMS Services
Key Benefits of GxP Auditing & Quality Systems
Global Compliance Assurance
Aligns operations with current GMP, GLP, and GCP standards across multiple jurisdictions (FDA, EMA, WHO).
Audit Readiness & Risk Reduction
Ensures inspection preparedness, reducing regulatory observations and costly post-inspection remediations.
Enhanced CAPA Effectiveness
Improves root-cause analysis and corrective-action traceability for measurable, sustainable quality outcomes.
Strengthened Quality Culture
Transforms compliance into operational excellence through proactive monitoring and continuous improvement.
Success Story
Pre-Approval Audit Prevents Critical FDA Observation
A mid-sized CMO faced a looming FDA PAI for a new drug facility, with insufficient readiness and data-integrity risks.
BQCIS performed a full simulation audit focused on Data Integrity, aseptic operations, and documentation flow—identifying critical gaps before the agency inspection.
Corrective actions implemented prior to inspection led to zero critical observations and on-time market authorization.