Our auditors carry out GMP / GMP compliance audits and assist you to ensure that your medicines (solid and injectable forms) are constantly produced and checked in accordance with current regulatory requirements. We carry out exhaustive or partial audits of your installations, QMS, processes, techniques and equipment.
Axys Network assists you in your PAI (Pre-approval inspection), carries out mock inspections in order to highlight weaknesses and non-compliance before any inspection by the FDA or any other regulatory agency (PMDA Japan, EMA, ANSM, ZLG, Anvisa , MHRA ...). We also audit CTD records and 510k and CE medical device records.
Profitez d'experts expérimentés et bénéficiez de leur expérience
From 8am to 8pm, simply contact
Axys-Network 566, route du Fronton Arrauntz 64480 Ustaritz France