PharmaPhix Ltd.

PharmaPhix is a pharmaceutical services company established in 2020, offering the following: QP batch release for EU, UK and non-EU pharmaceutical companies wishing to import into the UK or EU. Compliance inspection preparation for non-EU, EU and US authority approval. This includes: - Maintenance of existing manufacturing site authorisations - Green field site preparation and approval - US FDA PAIs – Pre Approval Inspections Consultancy to address EU critical audit observations, non-compliance reports, US FDA 483s and warning letters in order to re-establish authority approval and business continuity Conducting supplier compliance audits in accordance with ICH Q7 “Good Manufacturing Practice for Active Pharmaceutical Ingredients” and “ICH Q10 “Quality Management Systems” QP Declarations to support regulatory submissions and variations Review of product dossiers and associated analytical raw data prior to regulatory submission Assistance with product investigations in the event of an out of specification result. Contact us today: rmcneill@pharmaphix.com