Good Laboratory Practices (GLP) compliance supports preclinical operations for generating reliable, high-quality data crucial for drug development and regulatory submissions. At Pace®, our GxP Consulting team understands that adherence to GLP standards is fundamental to advancing drug programs – from IND-enabling tox studies to DMPK and ADME studies.
We offer quality assurance unit (QAU) and test facilities management (TFM) consulting to comply with 21 CFR Part 58 for conducting non-clinical laboratory studies. Quality Compliance for GLPs is central to support applications for research or marketing permits for products regulated by the Food and Drug Administration (FDA).
Whether you're a burgeoning startup conducting nonclinical lab studies at an external facility or are a GLP laboratory with targeted project requirements, our expert team provides knowledgeable support to ensure compliance with federal regulations. We immerse ourselves in your business, project methodologies, and unique challenges, applying our technical prowess, professional demeanor, and meticulous attention to detail to deliver practical solutions.
Our experienced professionals conduct both internal and third-party audits to rigorously evaluate compliance with GLP standards. We offer more than just formal audits; we provide insightful assessments of your existing quality systems, conduct thorough risk assessments, and identify areas for improvement.
Partnering with Pace® ensures you receive expert guidance to establish and maintain suitable, effective GLP compliance programs and systems. Our GLP audit services are designed to support your demonstration and maintenance of compliance through:
Third-party and supplier selection and auditing
Benchmarking against industry best practices
Comprehensive gap analysis
Strategic quality improvement initiatives
Critical phase inspections
Thorough regulatory inspection readiness programs
Robust GLP quality assurance is the cornerstone of trustworthy data. Beyond auditing, we support your team with essential training and program development. Our GLP training programs are designed to empower your personnel with the knowledge and skills required for unwavering compliance. We offer:
Specialized Good Laboratory Practice training, including vital topics like study director responsibilities, report-writing, and deviation-reporting.
Hands-on root cause analysis workshops to effectively address and prevent quality issues.
Comprehensive GLP training courses tailored to the specific needs of the pharmaceutical industry, available both in-person and as convenient GLP training online modules.
Facing audit or inspection findings? Our GLP compliance consultants specialize in effective remediation strategies. With a diverse range of experience and proven knowledge of the current regulatory landscape, our GLP consulting team provides actionable risk management recommendations for successful and sustained regulatory compliance. This comprehensive process may involve:
Detailed assessments of your current state
Strategic program development
Targeted employee training initiatives
Efficient remediation of identified issues
Leverage our SMEs to supplement personnel as QAU and TFM resources. We provide ongoing support services for:
Deviation management
Critical phase audits
Data audits
Facility management (personnel, resources, facilities, equipment, materials, and methodologies)
Our GLP expertise in the pharmaceutical and biotech industries ensures data integrity of GLP non-clinical laboratory data generated either internally or externally in support of marketing applications. Choose Pace® GXP Consultants as your trusted partner for all GLP quality assurance and compliance needs. We are dedicated to delivering practical outcomes that support your regulatory journey and advance your products.
Ready to Get Started? Connect with our experts to discuss your regulatory compliance programs.