Medicines Access

We provide the clinical expertise to improve patient adherence and persistence while ensuring patient safety at all times and deliver a complete solution across the drug lifecycle.

We have over 28 years of experience supporting pharma companies with early access including pre and post approval programs. As your partner, we can provide a proven supply chain, clinical support and data collection.

Supply Chain

Our supply chain for early access includes full GPS track and trace capabilities and bespoke delivery solutions. We also have regulatory licensing, which allows for the movement of pre-licensed products, and a fully licensed medical warehouse for all temperature regimes.

Clinical Support

Our clinical support for early access covers everything from our fully insured local nursing teams and 24hr multi-lingual care bureau for patients, to operational support which includes contracts and billing management, data security and country-specific reimbursement support.

Data Collection

We understand the importance of accurate data collection and everything that entails. That’s why we have pharmacovigilance and adverse event management reporting in place alongside either nurse-led, patient-led or wearable device technology to collect the data. Our data security and reporting are carried out to the highest standards and we’re GDPR compliant. We also have the capabilities to manage product quality complaints and carry out follow up testing.

Early Access Programmes (EAP) Project Management

When it comes to early access programmes, there is a lot to think about. That’s why we have dedicated project management teams in place to support you from day one and make sure everything runs smoothly. The scope of our expertise includes:

Individual Funding Request (IFR)

As well as early access programs, we can also provide support with your Individual Funding Request. We’ll make sure submissions are completed accurately and on time to help speed up approval.

  • We have a regional and national approach to IFR submission support packs created in conjunction with manufacturer
  • We support clinicians with the completion of the pack
  • We support clinicians with completion and submission of IFR process
  • We ensure timely IFR submissions, in respect of indicated approval time, to ensure smooth transition from MAP to IFR supply
  • We track and audit the progress for each IFR for manufacturer reporting purposes
  • We provide submission timelines and project management support to minimise delay for access and maximise opportunity for fast approval

A complete solution across the drug lifecycle

We offer a fully managed service across the drug lifecycle, designed to meet the specific challenges of launching and delivering orphan drugs for rare and ultra rare diseases to patients in Europe & beyond.

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