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”.
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.
Provide a full project management and regulatory function for a Centralised MAA for a virtual pharmaceutical company.
Obtain CHMP’s agreement on a change in development plan previously agreed.