Traxeus Pharma Services Information

Traxeus Pharma Services was founded in 2015 to deliver high quality, strategic regulatory affairs services and training to life sciences companies. Our founders bring a wealth of experience from the two opposing sides of the regulatory process. They have experience of managing and preparing submissions to European Regulatory Authorities and of evaluating marketing application authorisations at the MHRA in the UK. Our associates are experienced in regulatory affairs or have specific technical or quality expertise. We support product registrations in the Europe and China from generics and reformulations to new molecules and medical devices. Traxeus can help you navigate the regulatory pathways with the regulatory authorities, avoiding unnecessary delays, or worse, having an application rejected. Specifically we can prepare and review your submissions, represent you at meeting with European and Chinese regulatory authorities, and if required act as your agent. Gap analysis of the readiness of dossiers for submission is a key strength of our organisation. In addition, Traxeus can assess your project development plans to determine the most effective regulatory strategy.