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Pre Launch Access
Many established, as well as niche or start-up pharmaceutical and biopharmaceutical companies are keen on the prospect of launching products into multiple markets, but often do not have the resources and expertise to do so. Patients, meanwhile, are deprived of access to new life saving drugs, which are simply not available in their territory.
Mawdsleys offers a one stop shop service to facilitate market access in new territories, offering regulatory support, Controlled Access Programmes as well as named patient distribution across Europe and emerging markets, through our network of regional offices in LatAm, Asia-Pac and MENA. We can even help pharmaceutical and biopharmaceutical companies license their product into a territory, when the time is right.
Some countries cannot justify a formal launch nor may it be commercially viable to seek a marketing authorisation. Mawdsleys' extensive experience and expertise in many local markets enables manufacturers to install Controlled Access Programmes creating new demand and offering a direct route to patient access. Seemingly straightforward issues, such as the logistical importation process for non-locally registered medicines varies dramatically, even within the EU, from country to country, so having a partner with detailed knowledge of the relevant procedures and regulations saves both cost and time to market.
Mawdsleys endeavour to deliver an exemplary level of service in the supply of quality medicines to support unmet therapeutic needs and through our Controlled Access Programmes assist manufacturers to ensure their dedicated research effort reaches the patient.
Mawdsleys are also well placed to help pharmaceutical and biopharmaceutical companies license their niche products in a new territory, should the demand be significant enough. With specific expertise in the regulatory requirements of competent authorities and as specialists in niche pharmaceuticals, Mawdsleys can help clients efficiently get their products approved using QP batch release, ensuring all the required standards have been met.
For more information pharmaceutical and biopharmaceutical companies should e-mail firstname.lastname@example.org
Helping ensure patients have access to the drugs they need, when they need them.
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