See our work in action with these real-world examples.
Following the EC Recommendation 2013/473/EU, companies who do not design or manufacture the devices were to use the term “manufacturer”.
To authorise the exceptional use of a medicinal product that has not yet been granted marketing authorisation (MA). Such option is covered at European Community level in Article 5(1) of Directive 2001/83/EC, duly amended.
EUDRAC held a 2-day pharmacovigilance inspection by the German Competent Authority (BfArM).
Update an established Risk Management Plan (RMP) in the Revision 1 template to the Revision 2 template.
To perform a Periodic Safety Update Report (PSUR) in the European Union for a product which was not registered in the eXtended Medicinal Product Dictionary (XEVMPD) after recent marketing authorisation transfer.
Provide a full project management and regulatory function for a Centralised MAA for a virtual pharmaceutical company.
EUDRAC works with The EspeRare Foundation on a PRIME application for an orphan drug
Obtain CHMP’s agreement on a change in development plan previously agreed.
Post a regular pharmacovigilance inspection by a European Union (EU) National Competent Authority, a pharmaceutical company received a major inspection. The finding stated the requirement to regularly review and document changes in pharmaceutical regulations and guidance.