Pharma Companies | Mawdsleys Speciality Pharma

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

Distribution

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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