Seamlessly providing specialist pharma services
Pharma Companies

At Mawdsleys Specialist Pharma, we offer a broad range of seamless services for Pharma companies:

Named patient programmes

Regulatory and pharmacovigilance services

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 diseases, speciality pharma, oncology, haematology, critical care and orphan products

Named Patient Programmes

A Named Patient Programme (NPP) – often called an Early Access Programme – 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. Reasons why patients may not have a licensed treatment option available include a medicine being new and part of a clinical trial, or a previously licensed medicine being discontinued.


We have a successful track record of partnering with small and mid-size companies in launching such programmes, and are able to advise on their design, regulatory compliance and implementation. We can provide a bespoke, turnkey solution to provide patients with access to the medicines they need, while you’re able to see levels of demand and control the information passed to and from the healthcare provider. We will oversee access in accordance with your particular commercial and clinical parameters.

Managed Access
Compassionate Supply
Expanded Access
Early Access
Find out more about how we can help your pharma company at each stage of the licensing process:
Named Patient Supply

The Pharma Partner

  • Manages early demand via a reliable partner
  • Secures early sales in new territories without jeopardising future pricing
  • Increases company and product awareness in local territory
  • Establishes and enhances KOL network and patient advocacy groups

The Patient

  • Gains access to innovative therapies prior to launch in their country
Rapid Licensing

Rapid Licensing

  • Complete turn-key regulatory service covering all aspects of licensing
  • Strong contacts with local regulatory bodies
  • Access to advice from local regulatory bodies regarding the best approach in each individual case
  • Our experience in named patient supply can increase the possibility for accelerated registration
Accelerated Reimbursement
  • Extensive experience with national players and reimbursement bodies
  • Identification of the most appropriate reimbursement route depending on the product designation and unique characteristics
  • Access to specialist advisors to support our market access team in optimising the reimbursement case for each opportunity
Marketing and Sales
  • Highly targeted approach to building a market access strategy tailored to each individual project
  • Marketing activities led by MSLs, engaging with key clinicians involved in the targeted disease area
  • Unique access to historic market data and payors
Regulatory Affairs and PV
  • Experienced in-country regulatory specialists
  • Specialists covering registration, license maintenance, QA/QC and PV
  • Advice on most appropriate licensing routes according to the product designation
  • Extensive knowledge and experience of the regulations governing named patient supply
Sales Growth
  • Effective and thorough identification and analysis of the current and potential patient population
  • Networking with patient advocacy groups
  • Identifying early sales opportunities via named patient supply
  • Facilitating early reimbursement via named patient supply
  • Highly professional sales teams comprising experienced representatives and sales managers
  • Advanced targeting capabilities to enable focused efforts to drive growth
  • Established end-to-end distribution service into our core territories
  • Fully audited and approved by the UK MHRA, ANVISA in Brazil and the Israeli MoH
  • Supporting regular audits by our partners
  • Validation processes of all computerised systems, cold-rooms and warehouses to be positively assured of compliance
  • All procedures are subjected to a defined system of SOPs which are managed by the QA department
The benefits of launching a Named Patient Programme

Using our expertise and global experience, a Named Patient Programme can bring a range of benefits for your pharma company:


  • Helps to satisfy unmet patient needs in a local territory
  • Increases company/product awareness in a local territory
  • Establishes and enhances KOL (Key Opinion Leaders) networks and Patient Advocacy Groups
  • Commercial insight to help in launch decision
  • Captures pharmacovigilance data while complying with regulations
  • Gathers physician feedback on, for example, ease of use
Experts in product licensing

We’re well-versed in managing the whole process of getting your product licensed in new territories on your behalf, with wide-ranging experience in submissions to regulatory bodies, navigating the process and ensuring a smooth route to commercialisation.


With a focus on high added value products, we’re always keen to find breakthrough medical innovations for the healthcare community through in-licensing and long-term partnerships with small and mid-sized speciality pharmaceutical companies.

Let’s see what we can do for you

If you’re looking for a forward-thinking proactive partner with the knowledge, experience and capability to help your pharma company, we’d love to talk to you. So please get in touch.

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