Ensuring regulatory compliance and product quality is critical in cell and gene therapy manufacturing. Our Good Manufacturing Practice (GMP) compliance and Qualified Person (QP) services provide the oversight and expertise needed to meet global regulatory standards with confidence.
Consulting
GMP Compliance & QP Services
Why is GMP Compliance and QP Support Essential?
Cell and gene therapies are complex biological products requiring stringent regulatory compliance and robust quality assurance. Without expert oversight, companies risk delays in product release, regulatory non-compliance, and compromised patient safety. QPs play a vital role in ensuring that therapies meet Good Manufacturing Practice (GMP) standards, safeguarding quality and accelerating the path from clinical development to commercialisation.
A structured approach to GMP compliance and QP oversight ensures product integrity, regulatory alignment, and risk mitigation at every stage of manufacturing.
Our Process
Batch Certification and Product Release
In the EU, it is a legal requirement for a QP to certify that a CGT product meets all regulatory and quality requirements prior to release. This includes reviewing batch records, confirming compliance with GMP guidelines, supporting resolution of any quality events during manufacture and ensuring all necessary quality control (QC) tests have been completed.
Regulatory Compliance and Documentation
Adhering to regulatory guidelines from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA) is essential for product approval. Our QP team ensures that manufacturing processes, documentation, and compliance frameworks align with global regulatory expectations.
GMP Oversight and Inspection Readiness
Regulatory agencies require evidence that manufacturing facilities, processes, and personnel comply with GMP regulations. Our QPs provide GMP audits, compliance assessments, and inspection preparation to ensure companies meet regulatory expectations and maintain operational excellence.
Quality Control and Risk Management
Maintaining product consistency and safety requires stringent quality oversight. Our experts assess raw materials, in-process controls, and final product testing to ensure therapies meet defined potency, sterility, and purity specifications. We also support risk assessments and corrective and preventive actions (CAPAs) to mitigate potential manufacturing risks.
Our Approach
With over 40 years of combined experience in cell and gene therapy manufacturing, our QPs provide expert oversight tailored to the needs of each client. We ensure compliance at every stage, from early-phase clinical trials to commercial production, working collaboratively to build robust quality and compliance frameworks.
We are named across five different manufacturing licences and have supported over 30 clinical trials, providing the regulatory expertise and hands-on support needed to navigate complex GMP requirements.
Service Benefits
Regulatory Confidence
Ensure compliance with global GMP standards, reducing the risk of delays and batch failures.
Time to Market
Reduce time to market with expert QP oversight ensuring phase appropriate control of product manufacturing.
Risk Reduction
Proactively manage quality risks, preventing manufacturing issues that could impact timelines and patient safety.
Seamless Audit Preparation
Strengthening of the PQS and inspection readiness, ensuring smooth regulatory interactions.
Key Deliverables
Ensure Compliance with Expert GMP and QP Support
Meeting GMP standards is critical for advancing cell and gene therapies from development to commercialisation. Our experienced QPs provide the technical expertise and regulatory insight needed to ensure compliance, manage risks, and assure the Quality of products produced. Let’s work together to strengthen your GMP compliance and QP oversight. Contact us today.
