Enabling GxP compliance for drug development and manufacturing
The regulatory landscape for biopharmaceutical manufacturers has fundamentally changed. Global regulatory inspection volumes have returned to pre-pandemic levels. Unannounced inspections are at all-time highs. The number of facility-related corrective actions continue to rise — increasing the potential to disrupt operations and delay patient access to critical medicines.
Parexel's Strategic Compliance team stands ready to help you navigate these challenges.
With 40+ years of GxP compliance expertise and a team of 300+ strategic compliance consultants worldwide — including former FDA, MHRA, EU, and other regulatory inspectors — we deliver proven solutions that strengthen your compliance culture, mitigate risks and manage remediations. Combining deep regulatory knowledge with industry experience, we help you keep operations running so the products can reach patients faster.
Our experience with strategic compliance projects
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GxP client and supplier audits and mock inspections per year
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Form 483/Warning Letter/Consent Decree remediation projects
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Strategic advice on quality and compliance enforcement projects each year
Our GxP compliance services
We understand that one-size-fits-all approaches don't work in today's complex regulatory environment. That's why we tailor our solutions. By fostering collaboration and leveraging diverse expertise, Parexel provides comprehensive strategic compliance guidance including inspection services e.g., readiness, front/backroom support, and post-inspections response writing (e.g., FDA 483 and warning letter), data integrity assessments, targeted training, and quality management system development.
Enhance your operations, maximize efficiency and ensure regulatory adherence with our comprehensive set of services, including:
Services offered
Strategic advisory
Whether we're rapidly responding to an issue or building proactive compliance strategies, we help you confidently navigate risk mitigation, crisis management, and compliance — tailored to your unique situation, supply chain, and the patients you serve.
Our team of experts offer guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Quality Management Systems (QMS), and Good Distribution Practice (GDP). We can support in a variety of ways, including business continuity assessments, facility design reviews, staff augmentation/loaned executives services and more. Our expertise covers compliance support for sterile drug product fill-finish, biologics drug substance, and emerging technologies, such as cell & gene therapy and biologics-device combination products.
Auditing, inspection readiness, and training
Our detail-oriented auditing services help you stay ahead of compliance challenges. We conduct comprehensive GxP audits — including mock pre-approval/pre-licensing inspections (PAIs & PLIs), Bioresearch monitoring (BIMO) inspections, gap assessments, and corrective and preventive action (CAPA) verification audits. By proactively identifying areas for improvement and providing tailored training, we help you mitigate risks and maintain regulatory compliance.
We also prepare you for PAIs & PLIs with mock interviews, readiness assessments and application conformance reviews — with front/backroom support and response follow-up assistance to ensure successful outcomes.
Data integrity and compliance
Ensure sites GMP and GCP compliance, together with data integrity and build confidence in the quality of your data. Achieve compliance and data integrity through comprehensive audits, expert analysis, targeted training and streamlined procedure implementation – as well as staff interviews, internal investigations, and fraud evaluation that we support.
Quality management systems
A well-designed quality management system (QMS) — aligned with industry standards and regulatory requirements — provides the foundation for consistent compliance and reduces the risk of costly deviations. Parexel's Strategic Compliance team can evaluate your QMS to identify gaps, support effective change management, and implement targeted remediations that strengthen your compliance posture and operational resilience.
FDA, and other authorities, enforcement actions and remediations
Navigate warning letters and consent decrees with our strategic and operational compliance support. When faced with unexpected regulatory crises, we provide swift, well-balanced, and comprehensive responses to address the situation effectively. Starting with root cause identification, and delivering thorough remediation planning, implementation, and third-party oversight, we help you overcome regulatory challenges and restore compliance.
Our experts
Advantages
Proven track record
Our team has successfully remediated numerous sites and hosted pre-licensing inspections globally, resulting in FDA approvals and abbreviated inspections due to exceptional thoroughness.
Unparalleled expertise
Our team combines ex-regulatory experts with industry veterans to deliver pragmatic, informed solutions with deep understanding of regulatory requirements and industry standards.
Real-time regulatory insight
We maintain continuous engagement with regulatory agencies to provide up-to-date compliance intelligence and citation trends.