Our Services
Clinical Quality Assurance (GxP) services — in-house, on-site and remote — for Pharma, Biotech companies and Contract Research Organizations. Below is the full scope of consultancy and audit services available.
Clinical Quality Assurance (GxP) services
In-house, on-site and remote QA services for Pharma, Biotech companies and Contract Research Organizations.
GCP Consultancy
QMS concept and procedures development, review and implementation, Quality by Design and Risk Management, Gap analysis.
Investigator Site audits
Routine and for-cause audits of investigator sites for GCP compliance, across USA, Europe and APAC.
GCP, GDP, GVP Vendor audits
Vendor and third-party audits covering Good Clinical, Distribution and Pharmacovigilance Practice.
Trial Master File
TMF completeness, quality and inspection-readiness reviews.
CSR Audits
Clinical Study Report audits for accuracy, completeness and regulatory compliance.
Process audits
Audits of clinical operations and quality processes to identify gaps and drive continuous improvement.
Protocol audits
Review of study protocols for GCP and regulatory compliance.
MDD / MDR audits
Medical Device Directive / Regulation audits for device and combination product trials.
GCP Regulatory Inspections preparation and follow-up
End-to-end support for FDA, EMA, MHRA, PMDA and other Health Authority inspections.
Inspection Readiness
Proactive readiness assessments and mock inspections ahead of regulatory visits.
Send us a Message
Have a question about an audit, inspection or GxP consultancy engagement? Get in touch and we will get back to you shortly.