Understanding and evaluating the complex regulatory environment in different countries and for different types of projects is a challenging and time-consuming task. Ad Hoc Clinical constantly monitors the regulatory environment, keeping track of any changes in guidelines, regulations and local legislation.

Our regulatory experts and partners throughout Europe can play a key role by providing you with country-specific support.

Our regulatory services include initial submission, substantial amendment submission, notifications and applications for Managed Access Programs (Medical Need and Compassionate Use Programs) to regulatory bodies for clinical trials in drugs (proof of concept, first in men studies, Phase I to IV trials, registries and non-interventional studies, PAES/PASS studies, academic research, managed access programs, ATMPs,…) devices (clinical investigations pre- and post- CE label) and IVDs (performance evaluations).