Delivering excellence in biotech leadership and regulatory affairs.

Regulatory affairs expertise for leading cell and gene therapy products through clinical development to commercial approval in Europe and the US. A team of industry veterans who know what is required and how to navigate internal and external stakeholders to make sure the organisation achieves a pathway to move forward in an efficient and cost effective manner.

Our team have decades of experience in delivering:
- Clinical trial applications
- INDs
- Agency meetings: pre-IND, pre-CTA, national scientific advice, EMA protocol assistance, FDA Type B/Type C meetings, pre-submission meetings (MAA and BLA), ad hoc review meetings
- Designations (e.g. orphan drug designation, PRIME, ILAP)
- ATMP Classification
- Marketing Authorisation Applications
- Biologics License Applications
- Due diligence

Through our US and EU entities, we are able to be the Agency point of contact with FDA and EMA on behalf of clients.

PrimeRA Pharma Partners

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