# We are participating at RAPS 2023 - come and visit us at Boothstand 324 !
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.
During development, EUDRAC works with its clients to obtain Scientific Advice from the EMA and National Agencies. Through our experience of working with different agencies, we have gained a good understanding of their individual working practices and areas of expertise. This knowledge allows us to provide tailored support to our clients throughout the entire development and marketing authorisation application (MAA) process.
When it comes to the MAA process, EUDRAC supports its clients at every stage. We write, review, and submit all the necessary modules required for different application types. From start to finish, we oversee the complete procedure, managing the MAA throughout the assessment phase until the authorisation is complete. Our thorough approach and attention to detail ensure that our clients' applications receive the necessary scrutiny and meet regulatory requirements.
In addition to our regulatory expertise, our team has experience in a variety of therapeutic areas. This gives us a comprehensive understanding of the key regulatory topics that will be addressed in agency assessments. By drawing on this knowledge, we can assist our clients in developing a strong regulatory strategy that maximises their chances of success.
To further support our clients, we can provide detailed project plans customised to their specific development program. This ensures that all milestones and timelines are clearly defined, promoting transparency and effective communication. We also provide regular updates on changing regulatory requirements, ensuring our clients stay ahead of any new developments that may impact their applications.
In addition to our comprehensive services for the MAA process, EUDRAC also offers pre- and post-marketing pharmacovigilance (PV) services. We can handle all aspects of PV, including intelligence reviews and training for our clients. Moreover, our team is well-equipped to provide specific support for audits and inspections, ensuring regulatory compliance throughout all stages.
Finally, our extensive network of partners allows us to retrieve the latest regulatory requirements for EU and non-EU countries. This information enables us to establish the correct strategy to market a product or brand in a specific market, ensuring compliance and maximising market access.
In summary, EUDRAC offers a comprehensive suite of services for clients seeking regulatory support. From understanding individual agency practices to managing the entire life-cycle process and providing ongoing regulatory guidance, our team is experienced and well-versed in navigating the complex landscape of regulatory requirements.