Good Laboratory Practice (GLP)

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)