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)
News & Insights
September 10, 2025
FDA Launches Crackdown on Deceptive Drug Advertising
FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.
September 10, 2025
Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...
Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.
September 9, 2025
FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?
FDA will now release Complete Response Letters in real time. Learn what this transparency means for drug developers, investors, and the industry.
News & Insights
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
