PrimeRA Pharma Partners provides senior regulatory and development leadership for cell and gene therapy companies pursuing international development. Our partners bring extensive regulatory, CMC and clinical-development experience across the EU, UK and US. They work alongside client teams to provide clear direction, support critical decisions and maintain continuity through each stage of programme development.

PrimeRA brings together four core pillars: Leadership, Delivery, Representation, and Strategy & Insight. Our partners provide embedded senior regulatory direction, regulatory authoring and submission delivery, agency engagement, and independent strategic evaluation of programmes, portfolios and regulatory pathways. For eligible overseas sponsors, PrimeRA can also act as a named FDA US Agent, EU Representative and MHRA UK Representative, providing local regulatory presence across the US, EU and UK.

CMC leadership is integrated across these capabilities, connecting development and manufacturing strategy with regulatory requirements that shape clinical development and market access.

Our partners have contributed to the development, commercialisation and/ or maintenance of landmark advanced therapy medicinal products, including the first gene therapy approved in Europe, the first CAR-T cell therapy submitted for approval in the EU and US, the first CRISPR gene-editing product approved globally and the first gene therapy approval obtained in Europe and the US by a non-profit organisation.