EUDRAC takes pride in understanding your needs and developing long-term relationships with our clients by producing high quality work according to project timelines.
We offer customised packages to meet the requirements of both small and large healthcare companies and have become valued, integral members of the clients’ project teams.
Please see below more information on the services we provide.
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
In addition to European Union requirements, specific national requirements must be met throughout the different stages...Learn more