Our Expanded Access Program solution

Our partners benefit from our regulatory, marketing and commercial strategy expertise, ensuring a faster and easier route to market.

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A fully integrated Expanded Access Program (EAP) solution for your orphan drug

Regulatory assessment

We offer regulatory assessments for countries where you wish to implement an access program, advising on the most suitable type of program for your objectives, its potential for being chargeable, and the data you might collect.

Real-world data collection

Our service model incorporates real-world data collection, offering guidance throughout the regulatory process to ensure the collection of pertinent data, along with statistical and analytical support.

Established supply chain

Our logistics teams will ensure product is delivered most of the time within 24hrs of order confirmation. We will ensure there is full track and trace capability to allow auditing of all activity.

A digital platform for clinicians

We will ensure healthcare professionals are properly validated and given access to our online ordering portal. This will enable them to access the program’s documentation, product details, and any necessary training resources.

A dedicated account manager

A personal touch thanks to a dedicated account manager, a bespoke solution tailored to your specific needs, a strategy developed by our Director of EAP and a dedicated team that will implement it for you.

A multilingual customer service

Our international customer liaison team, based in Germany, is multilingual and proficient in most European languages. They provide a variety of support services and serve as the primary point of contact for hospitals and pharmacies.

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Get in touch

Hear from our EAP Director

Andrew Cummins, Director of Expanded Access Program at Sciensus, has more than three decades of experience in senior international commercial leadership positions within the Pharmaceuticals and Medical Devices sectors.

Over 30 years experience

Sciensus has a 30-year proven track record in global market expansion, and our team has extensive experience in the rare and orphan disease market.

relationships with healthcare providers, hospitals, wholesalers and pharmacies

orphan drugs bought and sold per year

units of orphan medicine supplied

Why choose Sciensus?

From EAP to full commercialization

We specialize in orphan drug commercialization across Europe. When your EAP completes and you move to commercialization, we can handle all your needs for commercial supply.

Expert in Europe and orphan drugs

Over 30 years we have built an expert understanding of medicines used to treat rare diseases and have built significant working relationships with hospital groups in the EU.

A truly patient-centric approach

We offer extensive experience in the design, development and delivery of digital and nurse-led patient support programs (PSPs) tailored to the needs of our clients and patients.

Schedule a free consultation

To discuss your challenges and create a strategy for accessing Europe tailored to your business needs, please complete the form below. Our Director of Expanded Access Program will contact you to schedule a meeting and provide a complimentary consultation

Let’s talk

Learn more from our experience

Read our thought leadership articles

Navigating Expanded Access Programs in Europe

Thought Leadership

Navigating expanded access in Europe: a strategic blueprint for biotech leaders

Navigating regulatory challenges in the EU

Thought Leadership

EU orphan drug roll out: navigating regulatory challenges

Sciensus_Fierce Biotech_white paper_final

Thought Leadership

Realize your European orphan drug expansion

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