Our GcLP auditing capabilities
We support our clients in assessing clinical laboratories across all phases of development by providing:
GcLP compliance strategy and implementation
Study-focused GcLP frameworks aligned to clinical laboratory operations, regulatory expectations, and evolving inspection standards.
Clinical laboratory quality management systems (QMS)
Design, remediation and optimization of laboratory QMS that support real workflows while maintaining inspection-ready compliance.
Data integrity and documentation controls
Pragmatic controls that protect data credibility, traceability and regulatory acceptance across clinical studies.
Audit and regulatory inspection readiness
Risk-based assessments, mock inspections and embedded support before, during and after regulatory audits and inspections.
Vendor, assay and method oversight
Oversight of outsourced laboratories, clinical assays and method transitions to ensure consistent GcLP alignment and study continuity.
Interim QA and laboratory compliance leadership
Flexible, project-based or interim QA team support to address resource gaps, inspection preparation and remediation activities.
Risk-based gap assessments and remediation
Targeted evaluations focused on study impact, with clear, actionable remediation that strengthens compliance without slowing trials.
