Our client, based in Europe, wished to launch formulations of a long-established systemic and topical antimicrobial agent into a new market.
Micron was commissioned to write Module 2 (clinical and non-clinical overviews and summaries) of the common technical document (CTD), which needed to be produced within tight deadlines. Our writers analysed and collated the existing clinical study reports (CSRs) and periodic safety update reports (PSURs) of the agent, and carried out extensive literature searches for further data. Most of the clinical studies dated back several decades, prior to the issuance of Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonisation (ICH) guidelines. Despite the paucity of data, our writers’ expertise enabled us to produce high quality product summaries that met current regulations, within the timeframe required by the client.