About Meridian Pathway

Meridian Pathway is a collaboration between PrimeRA Pharma Partners and eXmoor Pharma

Accelerating market entry for China-developed CGTs into the UK, EU and US

Cell and gene therapies developed and/or owned in China face a distinct set of challenges when progressing into UK, EU and US markets. Existing clinical and CMC data must be assessed against local regulatory expectations. Comparability and bridging requirements need to be understood and addressed, and regulatory, development and manufacturing strategies aligned for successful market entry.

The Meridian Pathway is an integrated offering that brings together specialist regulatory, CMC and manufacturing expertise to support China-originated ATMP programmes as they prepare for clinical development and longer-term progression to commercialisation in regions outside China.

PrimeRA Pharma Partners

PrimeRA Pharma Partners provides senior regulatory and development leadership for cell and gene therapy programmes across the EU, UK and US. Our partners integrate with client teams through four core capabilities: Leadership, Delivery, Representation, and Strategy & Insight. CMC expertise runs throughout our work, connecting regulatory strategy, technical development and global execution for advanced-therapy developers.

eXmoor Pharma

eXmoor Pharma is a cell and gene therapy specialist CDMO with embedded consultancy expertise. Founded in 2004, eXmoor supports clients across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. It guides projects from early CMC strategy to GMP manufacture with regulatory insight, IP freedom and a collaborative model that accelerates success.

— FAQ’S

Common Questions

  • Advanced therapy developers with established cell and gene therapy assets and/or China-generated clinical or CMC data who are considering development or commercialisation in the UK, EU and/or US.

    1. UK / EU / US readiness - assess China-generated data, CMC package and programme status.

    2. Regulatory & CMC strategy - define regulatory pathways and bridging needs, and progress engagement through agency meetings, scientific advice and CTA/IND planning and execution.

    3. Process & analytical readiness - close development gaps and support comparability, process and analytical development, and scale-up.

    4. GMP, supply & technology transfer - plan the manufacturing and supply route, including QP, importation and technology transfer requirements where applicable.

    5. UK / EU / US progression - support programme progression through clinical development towards commercialisation.

    • Integrated regulatory, CMC and manufacturing expertise through a single coordinated programme team

    • Specialist support for China-originated cell and gene therapy programmes entering UK, EU and US markets

    • Deep experience in ATMP regulatory strategy, agency interactions and market-entry planning

    • Expertise in comparability, bridging and development gap assessments

    • Access to UK GMP manufacturing capability for cell and gene therapy products

    • Support for technology transfer, supply chain design, importation and QP certification

    • Access to established networks across the UK, EU and US ATMP ecosystems

    • A coordinated pathway from strategic assessment through to clinical development and commercial readiness

  • No. A complimentary initial consultation is offered to discuss your programme and whether Meridian Pathway is relevant to it.

  • Your enquiry is received directly into a monitored inbox and reviewed by the relevant consultants, so the right person can respond to you directly.

  • No. We do not sell, rent or share your information with third parties for marketing purposes. Full details are set out in our Privacy Policy.

Get in touch

If you would like to discuss your programme, you can reach us directly at Info@PrimeRAPharmaPartners.co.uk