Strategic advice for drug registration
We have a team specialized in providing advice for drug and medical device development and registration.
We offer the experience from very high-quality medical experts from the Hospital Clinic together with the expertise from additional experts in critical areas (i.e., statistics, regulatory).
Regulatory strategy itself is a game plan calculated to obtain approval or clearance of a novel drug or medical device. As a matter of course, regulatory requirements are ever-changing, so a well-honed regulatory strategy can maximize the opportunity to achieve regulatory goals.
Insights
On Wednesday, June 7, a meeting of researchers from the iliCo study was held in Leipzig, as part of LINC 2023
Món Clínic is taking part in Scientific Advices provided by the experts panel in the pilot test opened by the EMA (European Medicines Agency) to manufacturers of certain high-risk medical devices, with the aim of guiding and helping them on their intended clinical development strategies and proposals for clinical investigations