Chemistry Manufacturing and Controls (CMC) Services

PharOS Ltd. offers a wide range of services which includes chemistry, manufacturing and controls. Features: it uniquely qualified to assist in managing CMC needs. The skilled practitioners provide companies with the in-depth experience they need to ensure the robustness of their CMC capabilities. Dossier compilation: communication with api & finished product manufacturer, raw data evaluation for ema guideline and eu authorities compliance, co-ordination with external experts for non-clinical & clinical overviews, modules 2-5 compilation in eCTD format. Dossier evaluation/ upgrade: review of raw data, identification of deficiencies, address major issues prior to receipt of authorities' comments, ensure smooth registration procedure with short clock-stop. Dossier registration procedure: assessment on authorities comments, co-ordination with api, finished product manufacturer and cro, evaluation of responses, compilation of response documents for modules 2-5. Medicinal product life-cycle: life cycle management, gap analysis, variations.