expanded access program services

Our Expanded Access Program services

Our comprehensive Expanded Access Program services

Full regulatory assessment

Sciensus will support you with a full regulatory assessment of the countries you are interested in running an access program. This will cover advice on type of access program most suited to your needs, whether it can be charged for or not, what data you may be able to collect. We can also advise on your communication strategy. You will be supported by a dedicated project manager, and a multilingual customer service team.

A digital platform for clinicians (​Sciensus Axcess)

We will ensure health care professionals are properly validated and given access to our online ordering portal Sciensus Axcess. Registered healthcare professionals will be able to view documentation for the access program including product information and any relevant training materials.

An 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. We can provide a full order to cash service. We will deal with any issues in an efficient, ethical and regulatory compliant manner.

EAP monitoring protocol and enhanced​ real-world data collection

At Sciensus, we excel in designing research protocols to capture and analyze real-world data, empowering you to make informed decisions throughout your product lifecycle. Our comprehensive support spans clinical study design, funding submissions, market access initiatives, post-market studies, and product evolution strategies. 

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.

Additional benefits

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Commercialization support

We can offer a true commercial partnership, with both licensed and unlicensed medicines. We are experts in the commercialization of orphan drugs across Europe, so when your EAP completes and you move to commercialization in that country, we can also handle all your support needs for commercial supply. We can also support access in non-commercialized markets using unlicensed medicines regulations

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A truly patient-centric approach

We also 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. Being patient-centric, pan-European and delivering value are the core principles behind all our PSPs.

Unlock European opportunities and revenue with Sciensus

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.

Our partnership model is designed to support the development and launch of therapeutics in the EU by allowing our partners to leverage our expanded access programs, world class supply chain, patient support programs and nursing programs. We also support biotechs by giving our partners access to our regulatory, marketing and commercial strategy expertise. In the last year alone, we supported our clients with over $350m of sales in Europe. This collaboration can not only ensure a faster route to market but also serves as a significant step in addressing the critical medical needs of patients reliant on timely access to advanced treatments.

Why partner with Sciensus?

Partnering with Sciensus reduces risk and adds value to your European expansion. We believe in making sure every family has access to rare disease medicines and the care they need. No matter where a patient lives or the regulatory governance of that country, we can safely launch and efficiently deliver vital medication and clinical services for families that need it most.

“Our bespoke, fully managed service is designed to meet the specific challenges of launching and delivering orphan drugs for rare diseases and ensure they can access your product, safely and as quickly as possible. Whatever your ambitions, we can quickly scale your business and help many more rare disease patients get the life-changing medication they deserve”. – Andrew Cummins, Director of Expanded Access Programs.

Book a meeting with me

Schedule a meeting with our EAP expert

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.

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