Consulting
Process Development
Analytical Services
GMP Manufacturing
Facility Design & Process EngineeringRobust Quality systems and Regulatory expertise are essential to delivering safe, effective, and compliant cell and gene therapies. Our integrated team brings the knowledge and experience to guide your product through GMP manufacturing with confidence.
GMP Manufacturing
GMP Quality & Regulatory
Why Quality and Regulatory Expertise Matters
Maintaining GMP compliance in an evolving regulatory landscape requires more than a checklist. It demands proactive quality systems, deep technical understanding, and clear documentation.
From clinical trial supply to commercial readiness, quality and regulatory oversight must be integrated throughout the product lifecycle.
Our Approach & Expertise
Quality Assurance is embedded across all our GMP activities. Our integrated QA team works closely with production and QC functions to maintain seamless quality oversight throughout every stage of manufacturing.
By ensuring all quality functions are joined up, from documentation and testing to audit readiness, we provide a fully aligned quality system that supports consistent, compliant delivery. This joined-up model also enables efficient cross-functional communication, reducing risk and minimising delays.
Our in-house QPs, quality specialists, and regulatory consultants bring deep expertise in CGT manufacturing and compliance, providing guidance, oversight and certification within our facility’s robust GMP framework.
GMP Quality & Regulatory Capabilities
GMP QC Testing
Our GMP QC laboratories support in-house release testing for cell and gene therapy products, using a range of validated analytical methods including qPCR, ddPCR, ELISA, Flow Cytometry, HPLC, DLS, and spectrophotometry. We collaborate closely with our Analytical Development team to ensure efficient method transfer and validation, and manage specialist testing through fully audited contract laboratories for product safety and characterisation.
Quality Assurance Oversight
We provide end-to-end QA oversight across all GMP manufacturing activities. Our electronic Pharmaceutical Quality System (ePQS) is structured to meet UK, EU and US regulatory requirements and is underpinned by knowledge management and quality risk management principles. The Quality Assurance team is embedded across production, QC, and QA functions, ensuring consistent compliance and operational alignment. Our team brings a wide range of experience in cell and gene therapy manufacturing, supporting the delivery of high-quality, regulatory-ready products.
QP Certification
Our Quality Assurance procedures are designed to fully support the QP in the certification and release of GMP batches. This includes detailed QA review of all manufacturing documentation and quality control data prior to QP certification. We provide QP certification and release for clinical products and QP compliance oversight for cell banks, and drug substance, ensuring every batch meets regulatory requirements before it is released for clinical use.
Build Confidence in Every Batch
From documentation to batch release, we deliver integrated GMP quality and regulatory support that keeps your therapy on track. Contact us today to discuss how we can support your quality and compliance goals.
