eXmoor Pharma provides contracted Qualified Person support for CGT manufacturers, CDMOs and organisations operating their own GMP facilities. From ongoing and backup cover to additional support during periods of increased certification workload, our QPs work within your Pharmaceutical Quality System, licence scope and operating model.
Contract QP Services for GMP Manufacturers and CDMOs
When QP capacity needs to flex with manufacturing demand
Manufacturing demand does not always grow in step with QP resource. A new programme, increased certification workload, planned or unplanned absence, or a period of operational growth can all put pressure on an internal team.
Contracted QP support can give you extra capacity when you need it, without forcing a permanent hire before the workload justifies one. The key is finding a model that fits how your site actually operates, with clear responsibilities, the right level of access and enough understanding of your products and quality system to support confident decisions.
Speak to us about contracted QP support.
Is QP capacity becoming a constraint?
Manufacturing demand does not always grow in step with QP resource. A new client programme, a rise in certification volume, an unplanned absence, or a change in product scope can all put pressure on a QP team that was sized for a different workload.
Recruiting a permanent QP with relevant CGT experience takes time and may not be the most efficient option where the need is part-time, variable or tied to a temporary period of growth. Contracted support can close that gap without displacing existing accountabilities or blurring who is responsible for what.
How we support manufacturers and CDMOs
Our QP services are scoped around your authorisation, products, quality system and workload. Support may include ongoing or fixed-term capacity, additional cover and wider quality input where certification or release responsibilities are affected.
Additional QP and quality support
Certification decisions do not happen in isolation from the wider quality system.
Where relevant, our QPs can also support:
- aseptic process simulation design
- contamination control strategy
- batch review workflows
- deviations, change controls and investigations
- supplier and contractor oversight
- audit and inspection preparation
- quality-system improvement
These activities are scoped separately where needed, but may form part of the wider support required to address issues affecting certification or release.
Where our QP experience can support your operation
GMP manufacturers and CDMOs
Support for specialist and multi-service CDMOs, integral developer-manufacturers and other GMP manufacturing organisations requiring additional, backup or specialist QP resource.
Organisations developing QP capability
Support for new or expanding sites, teams moving into CGT manufacturing, and organisations strengthening internal QP capacity or continuity arrangements.
CGT modality experience
Experience across genetically modified cell-gene therapies, Cell Therapy Medicinal Products, tumour-infiltrating lymphocytes and other oncology cell therapies, and lentiviral and AAV gene therapies, including supporting plasmids.
Why eXmoor Pharma?
Expert Insights
Beyond batch certification
Drew Hope, Senior Bio Manufacturing & Compliance Consultant and UK Qualified Person, explains what manufacturers should expect from a contract QP beyond batch certification.
In this short Q&A, Drew discusses the wider role a contract QP can play within a GMP manufacturing operation, including quality-system oversight, support for sound decision-making, training, audits, inspections and strategic quality input.
For manufacturers, that wider involvement can help identify issues earlier and support better-informed certification and release decisions.
Testimonials
Our Case Studies
Strengthening Quality Operations for an Allogeneic T-Cell Therapy Developer
Helped a clinical-stage allogeneic gamma-delta T-cell therapy developer regain control of quality operations and supplier oversight following organisational restructuring, without compromising compliance or product quality.
Building a CMC Roadmap for an AAV-targeting Platform
Developed a strategic CMC roadmap for Tavira’s AAV-targeting platform, aligning internal teams and investors around clear priorities for clinical development.
Ready to discuss your QP requirements?
Whether you need ongoing contracted support, backup cover or additional QP input as manufacturing activity grows, we can help define an arrangement that fits your authorisation, workload and internal capability.