Good Laboratory Practice Services
In nonclinical studies, data reliability and integrity are vital. Good Laboratory Practice (GLP) is the global standard for ensuring reliability, but achieving and maintaining compliance is a complex process.
FDA Quality and Regulatory Consultants (FDAQRC) eliminates this complexity with expert GLP compliance services. Our world-class consultants help pharmaceutical research teams, medical device manufacturers, toxicology departments and quality assurance professionals ensure their data is defensible, reliable and ready for review, simplifying market entry and improving brand reputation.
Understanding Good Laboratory Practice
Unlike Good Clinical Laboratory Practice, which applies to the analysis of samples from clinical trials involving humans, GLP governs nonclinical studies. It mandates a clear organizational structure with trained staff and an independent quality assurance unit for oversight. Facilities and equipment must be fit for purpose and correctly maintained.
All procedures are governed by standard operating procedures (SOPs) for consistency. Each study requires a formal protocol, and you must record all data accurately and securely archive it. These principles ensure the study results are traceable, reproducible and trustworthy for Food and Drug Administration (FDA), European Medicines Agency (EMA), and other Global Health Agency regulatory assessments.
Comprehensive GLP Compliance Services
We have designed a comprehensive suite of solutions to help your business achieve and maintain compliance with GLP regulations. Our core services include:
GLP Audits and Gap Assessments
Our experts begin with a thorough audit. We review your facility’s quality system, documentation and operational procedures against regulatory requirements. We identify critical gaps and provide a detailed report to guide your compliance efforts.
GLP Remediation and CAPA Implementation
Based on our audit findings, we partner with you to develop and implement a Corrective and Preventive Action (CAPA) plan. We help you address each gap, develop and improve your SOPs and build a quality system that facilitates lasting compliance.
GLP Inspection Readiness
Our inspection readiness program prepares your company, personnel and documentation for an FDA or international authority inspection. We conduct mock inspections and comprehensive gap analyses to ensure your processes and data are defensible and your team is adequately prepared.
Tailored GLP Solutions for Your Industry
Recognizing that GLP compliance presents unique challenges depending on the product, we offer specialized services tailored to the pharmaceutical and medical device sectors.
GLP for Pharmaceutical Research
In pharmaceutical development, the nonclinical pathway is under intense scrutiny, where data integrity is paramount. We partner with you to navigate the complexities of early-stage research with a special focus on minimizing study rejection, providing complex study support and ensuring defensible toxicology data. Our pharmaceutical toxicology services confirm that your study design and execution will withstand review.
GLP for Medical Device Testing
Proving material safety is an essential, nonnegotiable step for medical device manufacturers. Our expertise focuses on the specific demands of device testing, including biocompatibility, compliance, navigating unique documentation requirements and integrating GLP with a quality management system.
GLP for Specialty Labs
Our GLP expertise extends to diverse specialty laboratories, including those in the environmental, agricultural and chemical sectors. These industries face unique regulatory landscapes and require specialized study designs. Our tailored approach ensures that your specific testing methodologies, from environmental fate studies to chemical safety assessments, comply with regulations and generate defensible data. We also help you adapt quality systems for specialized workflows.
Why Choose Us for GLP Compliance Services
Our partnerships are founded on four core principles:
- A strategic and methodical approach: Every engagement is holistic to help you build a lasting compliance framework.
- An independent quality focus: We provide a meticulous, independent quality assurance function that serves as the cornerstone of data integrity.
- Commitment to defensible documentation: From SOPs to final reports, our focus is on helping you create documentation that withstands the highest level of regulatory scrutiny.
- Proactive regulatory partnership: We are your proactive partner in helping you anticipate changes, prepare for inspections and communicate effectively with regulators.
Beyond our proven methodology, we provide a unique combination of deep expertise, global reach and personalized service for project success. Our vetted global network allows us to pair you with the right expert for every project, regardless of location. We help you maintain a state of constant inspection readiness and continuous improvement through ongoing support and guidance.
With a dedicated internal project management team handling all the communication, you can have peace of mind knowing we are available to answer your questions and provide guidance.
Request a GLP Compliance Consultation Today
Experience faster market approval and increased brand reputation with a trustworthy GxP compliance consultant. Contact us today to request a GLP compliance consultation.
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