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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EUDRAC was proud to receive the Queen’s Award for International Enterprise from the Lord-Lieutenant of Oxfordshire (The Queen’s representative in Oxfordshire) on Thursday 6th September 2018. We were joined by clients, colleagues and families to celebrate the occasion. As our award was for International Enterprise, our overseas’ clients were not able to attend in person so below are some photos of the event.Read more
Brexit implementation period The MHRA has recently updated its information on the implications of Brexit, in particular on the terms that will be...Read more
It has been over a year since the EMA implemented Policy 0070 on the Publication of Clinical Trial Data; the EMA have published a guidance document...Read more