Pre-approval and Managed Access
Managed Access Consulting
Pharmaceutical and biotech companies know that if they decide to provide access to their medicines prior to commercial launch, they need to plan early.
They need to consider external stakeholders such as patients, healthcare professionals, regulators and payers, and they must balance this with their short- and long-term strategic objectives. They must be clear on what is both feasible and ethical. Getting this right is crucial.
Clinigen have an unsurpassed pedigree in developing early access strategies for many of the most innovative medicines and companies of the last 30 years.
With experience across 130+ countries, they have pioneered many of the early access consulting services, which are now standard across the industry. These include policy development, feasibility assessments, playbook creation, regulatory insights and independent ethics advice.
Clinigen have consulted with 19 out of the top 25 pharmaceutical companies and multiple small-to-medium biotech’s. They recognise that every client has different goals, and every patient has different challenges – there is no one-size-fits-all.
Clinigen’s flexible approach and industry-leading experience mean that their clients get the right solution – and patients get the right medicine.