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EAP Solutions

Expanded Access Program Solutions

Expanded Access Program Solutions

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Our streamlined expanded access programs transform lives and

accelerate product development.

Our streamlined expanded access programs transform lives and accelerate product development.

EAPs enable greater stakeholder connectivity and offer sponsors the opportunity to gather valuable real-world data that can assist with licensing and product commercialization.

Why choose Uniphar expanded access programs?

Our expanded access programs deliver controlled, pre-launch access to innovative therapies for patients with serious conditions who lack treatment options.

This allows patient access that transforms outcomes while responsibly gathering real-world insights to support product development and future availability.

We facilitate multi-region access to innovative therapies and are uniquely equipped to handle the complexity of diverse country-specific EAP regulations and supply chain networks.

Our coordinated expanded access programs provide a unified strategy to drive availability for a consistent brand experience and expedited patient impact whilst building real-world data.

Our proprietary technology platform, uniphi can help streamline your product’s journey to commercialization.

Asset-centric EAP design

We understand the value and importance of your drug asset.

Our team consults with you at length to understand your commercial and product objectives, and to identify the needs of all connected EAP stakeholders.

We take a strategic and personalized approach to program design to meet the identified needs, relying on 25+ years’ experience of delivering successful EAPs that optimize the benefits, while reducing the risks.

Best-in-class EAP support

Our expert team focuses on specialty drugs, rare diseases and oncology, and with wide-ranging EAP and industry experience.

They alleviate resource burdens to provide you with compliant and controlled access under specific regulations, while gathering meaningful data to support product development goals globally.

By efficiently navigating country differences and simplifying execution across geographic boundaries, we create expanded pathways that transform patient outcomes and accelerate therapeutic journeys to approval in chosen markets.

All supported by world class physical warehousing and distribution infrastructure across the US, EU, UK, MENA and APAC.

Asset-centric EAP design

We understand the value and importance of your drug asset.

Our team consults with you at length to understand your commercial and product objectives, and to identify the needs of all connected EAP stakeholders.

We take a strategic and personalized approach to program design to meet the identified needs, relying on 25+ years’ experience of delivering successful EAPs that optimize the benefits, while reducing the risks.

Best-in-class EAP support

Our expert team focuses on specialty drugs, rare diseases and oncology, and with wide-ranging EAP and industry experience.

They alleviate resource burdens to provide you with compliant and controlled access under specific regulations, while gathering meaningful data to support product development goals globally.

By efficiently navigating country differences and simplifying execution across geographic boundaries, we create expanded pathways that transform patient outcomes and accelerate therapeutic journeys to approval in chosen markets.

All supported by world class physical warehousing and distribution infrastructure across the US, EU, UK, MENA and APAC.

Global regulatory expertise in expanded access programs

Complex and distinct regulatory frameworks define the global expanded access program, landscape and often present planning and implementation challenges.

Our team has unparalleled knowledge of country-specific regulations and navigates them in a compliant and timely fashion, steering EAPs to success, while adding value and reducing risk. From development of a global regulatory strategy, to providing local hands-on regulatory services, our regulatory team stands by our clients at every step of the way, treating their investigational new drug with “white-glove” service.
World-class global distribution

We can hold stock, deliver and manage all distribution to hospitals and pharmacies across the world from our fully owned and secure global warehouses.

We manage the entire end-to-end process, taking full accountability through to product delivery. Our team of unlicensed product distribution specialists has experience with a wide range of drug types from chemical entities to biologics, including cell and gene therapies and controlled drugs under a wide range of storage and shipping conditions.

Powerful RWD technology to fuel your expanded access program

Insights from RWD can often complement data gathered from randomized clinical trials and are increasingly accepted to support decisions by regulators and payors.

Highlighting real-world patient and healthcare provider experiences, RWD can also add significant value to your product development and planning. uniphi, our robust proprietary RWD platform, is a one-stop solution for program management, enrollment, drug supply management, compliant capture of RWD and patient-reported outcomes.

The cloud-based technology is instrumental in truly improving efficiency of EAP processes for HCPs, sponsors and patients, and ultimately driving the success of your expanded access programs.

Let’s work together

A successful access program is, at its core, about collaboration. Partnering to provide patients with access to emerging and critical therapies, connecting all stakeholders in the access ecosystem. Working together we gather real-world data that assists product development and planning.