We offer bespoke support from a team experienced in preparing summary documents for regulatory submission. Including in vitro diagnostics, medical devices and clinical trials and the critical interface between these healthcare areas which is evolving under the recent EU and FDA legislation in these areas.
We offer support in the preparation of peer-reviewed manuscripts for publication and Systematic Literature Reviews. Systematic reviews are a critical component underpinning evidence collection to answer research question and are now expected as part of the clinical evidence collection manufacturers of in vitro diagnostic medical devices must provide to licensing authorities.
Tailored advice, support and scientific regulatory insights to enable organisations of any size, from multinational to start-up companies, to make informed decisions that help to rapidly satisfy the extensive and ever increasing regulatory requirements of the UK, EU and worldwide regulatory agencies.
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