Consultancy
Strategic regulatory consultancy and assistance in (early) product development phase
Strategic regulatory consultancy starts early in the development process and the selected route of submission determines the studies and data required. Kinesis provides regulatory input to project development plans. The goal is to provide sponsors with the optimal regulatory pathway, strategy and marketing opportunities for their product. Based on Kinesis’ long history in pharmacokinetics, there is a broad expertise to provide strategic regulatory and pharmacokinetic advice on bioequivalence programs, suitable for generic or abridged applications.
Kinesis provides assistance in regulatory processes during the (early) drug development phase, such as coordination of national or EMA/SAWP Scientific Advice, (pre) IND submissions and meetings, orphan drug applications, protocol assistance, and pediatric investigations plan (PIP). If requested, Kinesis submits clinical trial applications and takes care of the pharmacovigilance during the trial.
Kinesis’ regulatory consultants can be the regulatory expert in the sponsors’ development team and guide sponsors through all the regulatory challenges of drug development.