Axys-Network – Aseptic process consulting
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Quality audits and regulatory compliance

GMP audits by aseptic process experts

Checking that your production and quality control comply with current requirements, for injectable as well as solid dosage forms: facilities, quality system, processes, techniques and equipment, in full or partial audits.

GMP compliance audits

Full or partial audits of the site, QMS, processes and equipment.

Mock inspections

Identifying weaknesses and non-conformities before an FDA, EMA, ANSM, MHRA, PMDA, ZLG or Anvisa inspection.

Pre-approval inspections

Support for your PAIs.

Dossier audits

CTD dossiers and medical device files (510(k), CE marking).

Who we audit

Drug product manufacturers – bulk and fill & finish Suppliers, contract manufacturers, CMOs/CDMOs Biotechnology processes Active pharmaceutical ingredient (API) manufacturers Medical device manufacturers Primary packaging manufacturers Excipient manufacturers Cosmetics (ISO 22716)