REXPHARMA LIMITED

Rexpharma Limited is an Ireland‑based specialist that acts as an outsourced EU partner for the certification and release of clinical products. Leveraging its HPRA‑issued clinical Qualified Person (QP) authorisation (IMP MIA), the company enables sponsors to bring investigational medicinal products (IMPs) to European clinical trials with confidence and regulatory compliance.

The firm offers a comprehensive suite of services, including QP declarations and regulatory support, batch certification, quality and QP audits, and the provision of an outsourced quality department (QaaS). In addition, Rexpharma designs bespoke quality systems, optimises supply‑chain processes and delivers training and artwork development. Its expertise spans phase I‑IV programmes and covers a wide range of product types – from small‑molecule drugs to biotech, biologics, ATMPs and combination products.

Backed by more than 40 years of cumulative commercial and pharmaceutical experience and a track record of over 32 successful clinical trials, Rexpharma’s rapid regulatory success – securing its QP licence and GMP certificate in under 90 days – makes it a trusted ally for companies seeking to navigate the EU and ROW