EUDRAC is a European specialised regulatory affairs and pharmacovigilance consultancy company providing support to our clients to drive products through development, registration, market launch and post-approval activities across all EU countries.
EUDRAC is based in Germany, France and the UK, since 2002.About us
Taking several years of hard work and effort to get to a point where a product can enter the market, it is crucial to...Learn more
EUDRAC manages our clients’ Marketing Authorisation Applications submitted via both the Centralised and Decentralised/...Learn more
During the lifecycle of a medicinal product, the Marketing Authorisation has to be maintained according to up-to-date...Learn more
Being aware of regulatory requirements that are being developed, or discussed, by Regulators provides insight into the...Learn more
Pharmacovigilance (PV or PhV), also known as drug safety, is the science and activities relating to the detection,...Learn more
New regulations for medical devices entered into force on 25 May 2017. EUDRAC provide services for the development and...Learn more
The EUDRAC team have partners in all European Union countries and other regulatory regions. We undertake specialist...Learn more
EUDRAC Ltd is extremely proud to have won a 2018 Queen’s Award for Enterprise in the International Trade category.
The Queen’s Awards for Enterprise are the UK’s most prestigious business awards, recognising and celebrating business excellence across the UK
Our customised packages aim to meet the needs requirements of both small and large healthcare companies. We have become valued and integral members of our clients’ project teams.
This has lead to a high level of repeat business and ongoing long–term assignments with our clients and is proof of the excellent service EUDRAC provides.
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The MHRA has recently published a guidance for handling of centrally authorised products (CAPs) with assessment pending on EU exit day. Although the...Read more
BREXIT: Procedural Updates for Type I EMA variations The EMA is strongly encouraging MAHs to be prepared for Brexit to occur by the 12th of April...Read more
Webinar: EU Labelling Requirements The EUDRAC team is presenting a TOPRA webinar on the linguistic review process at the end of March. We will share...Read more