Protecting Patient Access. Enabling European Market Entry.

Bringing a medicinal product to Europe is about far more than obtaining a marketing authorisation. Time and again, we see companies invest years in development, clinical trials, manufacturing scale-up and regulatory submissions, only to discover that the operational realities of importing, certifying and distributing medicines across Europe are every bit as complex as obtaining approval itself.  At Orion GXP Consulting, we help pharmaceutical and biotechnology companies bridge that gap.

We work with organisations that need a practical, compliant route into Europe, whether that is launching a new product, establishing an importation pathway, transferring an existing supply chain, or resolving a challenge that threatens continuity of supply. Our focus has always been simple: helping to ensure that medicines reach the patients who need them.

An Award-Winning Partnership

In 2026, Orion GXP Consulting and Clinigen were honoured with the Life Sciences Industry Award for Best Strategic Partnership. The award recognised a project centred on Gliadel®, a life-extending oncology treatment used in the management of malignant glioblastoma.

The challenge was not simply regulatory. It required the rapid development of a sustainable European supply pathway, the establishment of compliant importation and batch certification activities, and close collaboration between multiple stakeholders with a shared objective: ensuring that patients continued to have access to a critical medicine.  By combining Clinigen's commercial expertise with Orion's regulatory, quality and importation capabilities, a compliant Irish importation and batch certification route was established, protecting supply continuity and creating a long-term solution for the European market.

The award itself was a proud moment for both organisations, but what mattered most was the outcome. Patients continued to receive treatment, healthcare providers maintained access to an important therapy, and a complex regulatory challenge was successfully transformed into a sustainable operational model.

Turning Strategy into Reality

Many consultancies can advise on European market entry. Far fewer have practical experience implementing the solution. Our team works at the intersection of regulatory affairs, quality assurance and pharmaceutical supply chain operations. We understand that successful market entry requires all three disciplines to work together.  A product may have regulatory approval, but without a compliant importation strategy, an appropriate quality system, Qualified Person oversight and a functioning supply chain, patients still cannot receive the medicine.

This is where we help.

Through our Irish Manufacturer's Import Authorisation (MIA), our network of experienced Qualified Persons and our deep understanding of European regulatory requirements, we support companies in developing practical pathways from manufacturer to patient.  Every project is different. Some clients require support in establishing a compliant Annex 21 importation model. Others need assistance designing a European operating structure, selecting supply chain partners, implementing quality systems or preparing for commercial launch. Increasingly, we are helping organisations navigate complex product transfers and supply chain transitions where continuity of supply is critical.

Whatever the challenge, our role remains the same: bringing together the regulatory, quality and operational expertise needed to deliver a workable solution.

Why Orion?

At Orion GXP Consulting we have assembled the best of the industry here in Ireland which has become one of the world's leading pharmaceutical hubs and provides an excellent gateway into the European market.  Its strong regulatory reputation, established pharmaceutical infrastructure, highly skilled workforce and access to the wider European Union make it an attractive location for companies seeking a compliant and scalable route to market.  For many organisations, Ireland offers an efficient way to establish importation, batch certification and release activities while maintaining oversight of a broader European supply network.

We support pharmaceutical and biotechnology companies from around the world, including organisations based in the United States, China and other non-EU territories that are preparing to enter the European market. Some are launching innovative therapies for the first time. Others are acquiring products, restructuring supply chains or looking for a more sustainable route to European patients.

What they have in common is the need for practical guidance from people who understand both the regulations and the operational realities of bringing medicines to market.

Let's Start the Conversation

Whether you are planning a European launch, evaluating importation options, transferring a product into Europe or facing a supply chain challenge that threatens continuity of supply, we would be pleased to discuss your objectives. The success of the Gliadel project demonstrated what can be achieved when regulatory, quality and supply chain expertise are aligned around a common goal.

If you are looking for a partner to help turn a European market entry strategy into an operational reality, we would welcome the opportunity to speak with you.

💊 If you require support with importation or commercial batch certification, please contact:
📩 admin@oriongxp.com | ðŸŒ www.oriongxp.com

We have also put together a handy EU Product Launch checklist, which you can use to test your European readiness and you can download here.