Good Laboratory Practice (GLP)
ProPharma ensures global GLP and lab compliance with QMS development, inspection readiness, remediation, and quality oversight.
GLP Consulting Services
ProPharma's Quality & Compliance team offers Sponsors, laboratories, and CROs a full range of global good laboratory practice and compliance support services for Clinical Study, Pharmacy, CMO, CDMO, CROs, and third-party testing labs. We assist in achieving and maintaining full compliance with GLP, GCLP, OECD, CAP, and CLIA regulations. Our consultants combine deep regulatory knowledge, operational experience, and a global perspective to ensure your non-clinical, clinical development, and bio/analytical programs meet international standards to support compliance aspects such as:
- GLP QMS development and implementation
- Inspection readiness
- Remediation
- Quality oversight

Nonclinical GLP Laboratory Compliance Services
We offer comprehensive Good Laboratory Practice support for facilities, sponsors, and testing labs conducting regulated nonclinical safety and toxicology studies.
Our GLP services include:
- GLP Facility & Study Conduct Audits
- Bioanalytical and Histopathology Compliance Assessments
- Test Article and Specimen Handling Reviews
- Toxicology Study Design and In-Life Phase Oversight (In-Vivo / In-Vitro)
- Data Integrity Audits (21 CFR Part 11, OECD, ALCOA+)
- Regulatory Inspection Readiness (FDA, EMA, MHRA, PMDA)
Enabling IND/CTA/NDA Laboratory & Testing Compliance
We support the transition from discovery through Investigational New Drug (IND) and Clinical Trial Application (CTA) to New Drug Application (NDA) testing with compliance audits, quality management system support, data integrity monitoring, and QA oversight services.
Our services include:
- GLP Oversight of IND/CTA-Supporting Studies
- CRO and Laboratory Qualification Audits
- Electronic Lab System Assessments (LIMS, ELN, CDS)
- Sponsor Oversight SOPs and GLP Quality Systems
- Regulatory Submission Readiness (IND, CTA)
GCLP, CAP & CLIA Compliance for Clinical Trial Laboratory
Ensure your clinical trial testing laboratories meet GCLP, CLIA, and CAP requirements to support compliant and inspection-ready operations.
GCLP Compliance Services
For central labs, specialty labs, and sponsor-oversight programs:
- GCLP Audits and Mock Inspections
- SOP Development for Sample Handling and Bioanalytical Testing
- Chain of Custody and Logistics Reviews
- Laboratory Vendor Qualification and Monitoring
CAP/CLIA Compliance Services (U.S. Labs)
For clinical labs performing testing under U.S. regulations:
- CLIA Certification Consulting and Gap Assessments
- CAP Accreditation Preparation and Inspection Readiness
- QMS Implementation and Lab Process Optimization
- Response Planning for CAP/CLIA Deficiencies
- Audit and Validation of Laboratory Information Systems (LIS)
Clinical and CMC Transition Support
We support clinical development teams as they interface with data from nonclinical and early CMC programs.
Services include:
- GLP-to-GCP Data Traceability Audits
- Oversight of Bioanalytical Labs Supporting Clinical Trials
- Companion Diagnostic and Biomarker Lab Compliance Reviews
- Technical Transfer
and Method Transfer Compliance Reviews - GCLP/CMC Consulting for Clinical Sample Analysis
Analytical Testing Compliance for Sponsors
We help commercial and manufacturing organizations manage GLP-related functions within GxP environments.
Services include:
- Non-GMP Laboratory Phase Appropriate Best Scientific Practices Compliance
- GLP Audit of R&D Labs within GMP Sites
- Analytical Method Transfer Compliance Support
- Stability and Shelf-Life Study Review
General Laboratory Compliance Services
Whether you're preparing for an inspection or establishing your first QA system, our global consultants can help.
- Global Regulatory Intelligence (FDA, EMA, MHRA, OECD, WHO)
- SOP Development & GLP/GCLP Policy Creation
- Staff Training (GLP, GCLP, CAP, CLIA, Data Integrity)
- CAPA Planning
and Remediation Project Management - Mock Inspections and Enforcement Readiness Support
- Quality System Development and Staff Augmentation
Partner with ProPharma for Good Laboratory Practice Services
Partner with us for expert laboratory compliance and quality solutions. Contact ProPharma today to learn how we can support your organization's laboratory Quality Assurance needs.
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