DLRC is a dedicated consultancy team of highly qualified and experienced Regulatory Affairs professionals.
The EU Clinical Trials Regulation (CTR) entered into force on 31 January 2022 and is now mandatory for all new applications as of 31 January 2023.Find out more
See what our clients have to say about DLRC
Thank you so much for your support and for guiding us through the entire process! Especially the last couple of weeks were so intense and have shown how important a well aligned team is! Great job everyone … You were our compass all the time… you were always spot on when needed; and all the time, you gave us the confidence to get where we wanted to be at the end.
We wanted to extend our thanks for all of your hard work, expertise and thoughtful partnership … You have been instrumental in operationalizing … capabilities we have been building together across people, process, tech, and content. We know that it hasn’t been easy at times because we are building something totally new and consider you a great partner to navigate this with. We are really looking forward to our continued work … Thank you!”
I take this opportunity to thank you for your initiative and agility in leading regulatory response and strategy in unexpected circumstances … Your support is indispensable and highly appreciated.
I would like to thank DLRC for the great leadership of the filing team and the fantastic preparation and chairing of the pre-submission meeting with the team and rapporteurs. It is great to have your experience and expertise on board for this important filing. The team managed to get all possible information from the rapporteurs in a fruitful and professional atmosphere, fostering great communication amongst the attendees.
We’d like to acknowledge DLRC for their hard work and ‘whatever it takes’ mindset during the recent project activities they completed for us, including key protocol amendment submissions made across multiple countries.
As a small biotech company with no facilities in Europe, we needed a strong partner to represent us and to support our global initiatives. The team assigned to our program has provided a broad range of regulatory expertise and operational support, and has been thorough, organized, responsive, and a pleasure to work with. The onboarding of the DLRC team was seamless, and they made efforts to familiarize themselves with our product and program right away so that they could contribute to both strategic planning and execution. I look forward to continuing our partnership as we progress our program.