Global Named Patient
Programmes
Global Named Patient
Programmes
Medical Affairs &
Pharmacovigilance
Distribution and logistics
aligned with GDP
Full product registration and
regulatory affairs support to
license and commercialise
products in Brazil, Israel and the UK
In country Marketing and Sales teams
specialising in rare disease, speciality
pharma, oncology, haematology,
critical care and orphan products
A Named Patient Programme (NPP) provides a safe, legal and ethical route for physicians and patients to access medications that have not yet been licensed or made commercially available in their home country. It is also often called an Early Access Programme.
Examples of why patients may not have a licensed treatment option include when a medicine is new and has not yet been approved in their country because a clinical trial in which they have been enrolled is finishing, or because a previously licensed medicine has been discontinued.
Mawdsleys Specialty Pharma has a track record of successfully launching such programmes by partnering with small and mid-size companies to advise them on suitable programme design, regulatory compliance and successful implementation.
In all these cases, Mawdsleys can provide a bespoke, turnkey solution which will provide patients with quick and ethical access to the medicines they need.
By centralising access for patients through Mawdsleys, the pharmaceutical company will gain visibility of demand, as well as control of the information which passes to and from the healthcare provider. This access will be fully controlled by Mawdsleys in accordance with the particular commercial and clinical parameters agreed with the pharmaceutical company.
Managed
Access
Compassionate
Supply
Expanded
Access
Early
Access
For pharmaceutical companies who want to get their products licensed in new territories, Mawdsleys Specialty Pharma has the expertise to manage this process on your behalf. Using the skills and extensive experience within the Mawdsleys Group, we can manage submissions to regulatory bodies on behalf of pharmaceutical companies, navigating the process to ensure a smooth pathway to commercialisation.
Mawdsleys Specialty Pharma is dedicated to seeking breakthrough medical innovations for the healthcare community through in-licensing and long term partnerships with small and mid-size specialty pharmaceutical companies. We are particularly focused on high added value products that require a well-established partner with a track record of success stories.
The Pharma Partner
The Patient
International House
4 Houston Park, Montford Street
Salford
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