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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

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Research & Development

Taking several years of hard work and effort to get to a point where a product can enter the market, it is crucial to...

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Marketing Authorisation Applications

EUDRAC manages our clients’ Marketing Authorisation Applications submitted via both the Centralised and Decentralised/...

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Post-Authorisation

During the lifecycle of a medicinal product, the Marketing Authorisation has to be maintained according to up-to-date...

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Global Regulatory Intelligence

Being aware of regulatory requirements that are being developed, or discussed, by Regulators provides insight into the...

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Pharmacovigilance

Pharmacovigilance (PV or PhV), also known as drug safety, is the science and activities relating to the detection,...

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Medical Devices

New regulations for medical devices entered into force on 25 May 2017. EUDRAC provide services for the development and...

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Specialist Services

The EUDRAC team have partners in all European Union countries and other regulatory regions. We undertake specialist...

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Specific National Requirements

In addition to European Union requirements, specific national requirements must be met throughout the different stages...

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Cosmetics

Classification of cosmetic products requires the combined knowledge of local regulations, intended use and mode of...

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The Queen’s Awards for Enterprise

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
 

Contact us, we are here to help you

Our customised packages aim to meet the 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.

Contact us below to help you to achieve your goals!

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