Epidarex Capital invests in early-stage, high growth life science and health technology companies in under-ventured markets within the UK and US. Epidarex funds the commercialization of ground-breaking research and new technologies to address large and unmet needs in today’s healthcare market.
ERA is able to contribute at any stage of product development, from discovery, through process development, non-clinical and clinical aspects, to regulatory approval and beyond. One of our recognised specialities is the design of a regulatory strategy, to cover part or all of the development process. Thus, our services include the following: Regulatory due diligence exercises for in- or out-licensing, interactions with regulatory agencies, such as pre-IND, pre-BLA and scientific advice procedures, clinical trial applications, marketing authorisation applications, including eCTD submissions, post-approval amendments or variations, advice on process development, including validation, input on characterisation and control, consulting on non-clinical and clinical strategy, facility inspections and support for establishment licensing.