Strategic and Regulatory Consulting
Strategic and regulatory consulting starts early in the drug development process. The selected route of submission determines the preclinical and clinical studies and data required. Kinesis Pharma regulatory consulting department 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.
Kinesis provides regulatory affairs assistance 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).
Our regulatory consultants can be the regulatory expert in the sponsors’ development team and guide sponsors through all the regulatory challenges of drug development.
Based on Kinesis Pharma's long history in pharmacokinetics, there is a broad expertise to provide strategic regulatory and pharmacokinetic advice on bioequivalence programs, suitable for generic/ANDA or abridged applications/505(b)(2) applications.
Kinesis can support with the development of a regulatory strategic plan for nutraceuticals, functional foods and dietary supplements.