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Referral Management Service

When this generic international pharmaceutical company found its promising pan-European license application suddenly encountering an unexpected problem, it turned to ELC to navigate the complex referral process and get back on track to achieve the all-important approvals it needed to go to market.

Customer challenge

Part way through a 200 day procedure to license its medicinal product in 30 European countries, this pharmaceutical company found itself facing a potential license suspension thanks to a health concern raised by assessors at a single EU agency. The procedure was one day away from a successful closure.

Failure to achieve a license would represent the loss of 18 months’ time and thousands of dollars of investment to bring the product to market in Europe.  Even in the event the license proceeded successfully, the referral process itself risked a potential delay of up to 80 days which would seriously impact the company’s credibility with its local distribution partners and represent significant cost to all concerned.

With a major EU referral meeting on the horizon the pharmaceutical company needed to respond fast, and turned to ELC Group to help.

ELC Group solution

ELC Group was able to instantly respond and in a matter of days had communicated with assessors in all EU agencies concerned in a bid to uncover the true issue. Alongside preparing for the all-important EU referral meeting, ELC Group’s crisis management team actively managed the expectations and needs of the pharmaceutical company’s extensive European partner network.

ELC Group reviewed all submission materials and was able to confirm quickly that the documentation was robust. With this established, ELG Group next drew on its extensive network of experts – many of whom have previously worked as assessors in the EU agencies involved – to reach out to the regulatory bodies and, using its extensive networking contacts, establish the exact grounds for the referral decision.

Business benefits

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