Primera Pharma Partners

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.