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:

smiling-woman-high-fiving-coworker-as-983431523-650x425

Illustration of ProPharma's Good Laboratory Practice (GLP) services overview

 

Gloved hand working with test tubes and vials in a lab

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)
Woman focused on injecting test tube

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.

News & Insights

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News & Insights

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Discover how ProPharma's medical information services in the Netherlands ensure patient safety, regulatory compliance, and data privacy with expert support.

Tips for Preparing Successful FDA 510(k) Submissions

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Tips for Preparing Successful FDA 510(k) Submissions

Discover essential tips for preparing a successful FDA 510(k) submission. Learn common pitfalls to avoid, align with FDA expectations, and streamline your path to clearance.

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Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

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...

ProPharma Recognized for AI Excellence at ECCCSA

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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.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

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.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

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.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel Therapeutics, Inc. - ProPharma

October 6, 2025

Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel ...

When BioXcel Therapeutics’ pivotal Phase 3 study faced a critical slowdown, timelines and regulatory goals were at risk. With their primary CRO unable to meet growing demands, ProPharma stepped in —...

Whitepapers Your Complete FDA 510(k) Premarket Notification Checklist

September 30, 2025

Your Complete FDA 510(k) Premarket Notification Checklist

Step-by-step guide to navigating the FDA 510(k) submission process with confidence Submitting a 510(k) premarket notification is a critical milestone for medical device manufacturers seeking U.S....

Infographic Unannounced FDA Inspections Without Borders - ProPharma

September 19, 2025

Unannounced FDA Inspections Without Borders

Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...

Previous Resource Arrow Next Resource Arrow
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October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

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Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

Medical Information (MI) and Pharmacovigilance (PV) work together to protect public health by identifying and evaluating emerging safety signals. Watch our in-depth webinar, where our experts explore...

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September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

Previous Webinar Arrow Next Webinar Arrow