Axys-Network – Aseptic process consulting
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Pharmaceutical consulting firm

Aseptic process experts, from troubleshooting to interim management

We work on sterile injectable manufacturing sites: continuous improvement, problem solving, compliance with ANSM, EMA and FDA requirements, and strategic projects.

Cleanroom operator working at the glove ports of an isolator

Expertise

Five areas, one network of field experts

All our consultants have real shop-floor experience. On site, they draw on our back office of experts to cover the complementary aspects of each assignment.

Manufacturing Aseptic processes, technology transfer, media fill tests, cold chain, CMO selection, due diligence. Learn more → Quality Audits, ANSM and FDA inspections, Annex 1, deviations and CAPA, data integrity. Learn more → Engineering Bioprocesses and monoclonal antibodies, pharmaceutical water, HVAC, PLC-SCADA, maintenance. Learn more → Lean Production, quality control, packaging, maintenance and pharmaceutical documentation. Learn more → Training On-site modules: APS, sterility assurance, Annex 1, sterilisation, isolators. Learn more →

Key topics

Manufacturing Media Fill Test (APS) Running and troubleshooting your media fills, defining your strategy. Quality Sterility assurance level Control your SAL and classify the probability of a non-sterile unit. Quality EU GMP Annex 1 Gap analysis, contamination control strategy (CCS), training. Quality GMP audit Compliance audits against pharmaceutical standards.

Selected assignments

All case studies →
Expertise · India Aseptic practices for a biologic intended for the US market 5 days on site, 200 people trained, products on the US market Expertise · France Site remediation after a difficult ANSM inspection 4 experts for 3 months Interim · Europe Construction of a large biotech plant Many interim managers, over several years

Interim management

More than an interim manager: an expert who moves your projects forward

Our interim managers all come from our network of experts. Selected for their technical skills and experience, they are operational at very short notice.

Full time or part time Assignments of 4–5 days or 2–3 days a week, depending on your needs.
Profile matched to objectives Objectives are set before the assignment so that we can propose the best-suited profile.
Backed by the network The manager consults our experts to act quickly and effectively.
Skills transfer The know-how passed on to your teams stays after the assignment ends.

The Axys-Network network

Experts from several countries, used to ANSM, EMA and FDA requirements

Pharmaceutical site management, manufacturing, quality, regulatory affairs and support functions: the network covers most of the skills in demand and applies current best practice.

Recognised experts
Alain EuzenCompliance
Patrice RomainSterility assurance
Marc BessonAseptic practices
Franck PavanBioprocesses

More than 20 talks at international conferences since 2002: A3P, PDA, ISPE, European GMP Conference… See the conferences →

Seen on BFM Business

Axys-Network on the programme Décryptage

Franck Pavan and Eric Latour, partners at Axys-Network, present the firm: the design of pharmaceutical plants, a very hands-on business, and consultants who work side by side with their clients' teams.