Clinigen empowers companies like yours with a seamless blend of global expertise and local knowledge, guiding you confidently through even the most challenging regulatory landscape.
Working alongside you to advance groundbreaking medicines or cutting-edge medical devices, we deliver insights through our team of experts and advisory board. We capitalise on those insights through execution of strategy and expert regulatory writing. From concept to commercialisation, we craft bespoke strategies aligned with – and driven by – your goals.
We turn challenges into opportunities, accelerating approvals and unlocking the potential of your innovations by anticipating the demands of licensed and unlicensed pathways.
As your marketing authorisation holder, we help you to enter new markets and move confidently into your product’s commercialisation phase.
Our end-to-end approach ensures smooth transition from development to approval and beyond, covering the whole suite of your regulatory needs, including strategy and submissions, medical writing and lifecycle maintenance.
Combining global reach, local knowledge and strategic expertise, we enable innovators like you to do what you do best – to innovate.
Expanding Our Expertise in Regulatory Affairs: Clinigen Acquires Kinesys Consulting
We're excited to announce the acquisition of Kinesys Consulting, a leading provider of strategic regulatory affairs, regulatory/medical writing, and medical devices services for the pharmaceutical and biotechnology industries. This strategic move strengthens our existing regulatory capabilities and allows us to offer an even more comprehensive suite of services to our clients. By combining our strengths, we can offer a seamless path to market, guiding clients through every stage of the drug development journey, from early development to commercialisation. Read more about this acquisition here