• Aseptic Processing Experts 

    Troubleshooting & Continuous Improvement

    Our Services
  • Transition Management Pharmaceutical Assignments

    From our pool of experts in aseptic processes to ensure not only an interim but above all to bring you the expertise necessary for the advancement of your projects.
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Aseptic Processing Experts 

 Our Mission

Axys-Network is a pharmaceutical consulting firm specializing in aseptic processes. We intervene within the framework of your policy of continuous improvement, in troubleshooting as well as for your strategic projects. These interventions cover support for the management of a pharmaceutical establishment, manufacturing, quality services and CMC activities. To ensure the effectiveness of our interventions. the on-site experts are supported, via our back office, by other experts covering aspects complementary to the current mission.


 Our Experts

All of our consultants are field experts with real shopfloor experience in their area of expertise. They intervene directly on the sites, using their know-how and experience in order to implement the expertise of our network. To ensure the effectiveness of our interventions, we offer services already implemented on other production sites and having demonstrated their relevance in a pharmaceutical factory

 The Network of Axys-Network

Axys-Network has a vast network of experts from various countries, governed by their respective agencies - ANSM-EMA-FDA- and covering a large part of the skills sought: Pharmaceutical Management, Manufacturing, Quality, Regulatory Affairs as well as other Support functions. The proper functioning of the network ensures its efficiency and allows interventions applying the best current practices.

​  Our Services

Compliance
Technologies
Transition
Support
Technologies
Axys-network
Troubleshooting & Amélioration Continue
Aseptic Processing
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mAbs
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Downstrean Process
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 Protein Aggregation
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Technology Transfer
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Troubleshooing & Investissements
Pharmaceutical Water
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Cold Chain  
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Réduisez fortement vos consommations d'énergie
HVAC
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Automate-SCADA
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Support
Inspection Support
Preparation and support for ANSM regulatory Inspections
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Due diligence
Support with expertsfor your Due Diligence
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CMO/CDMO
Search and Selection of CMO & CDMO 
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Audits
​Compliance audits to the pharmaceutical standards
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Training 
Modules related to the  missions carried out
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Engineering
​Consultants-experts in Engineering
Support MOA & MOE
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Lean
Modules implemented by pharmaceutical experts
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Compliance
Gap Analysis Vs Annexe 1 --- Contamination Control Strategy CCS--- Formaion Annnexe 1
GMP Annex 1 
Gap Analysis - Contamination Control Stratégy - Training
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FDA Support
Gap analysis - Support for  PAI's & FDA Inspections 
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Media Fill Test
Support for the realization of MFT
Definition of your MFT Strategy
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Backlogs
Deviations & CAPA Backlogs - Processes Redisign
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Risks Management
Risk analysis of your Processes & new installations
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Quantify Your Risks
​Perform an exhaustive analysis and Quantify all your risks
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SAL
Master your SAL, Rank the probability of non-sterile product 
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Human Errors Prévention 
Original method of preventing human errors
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Data Integrity
Gap assessment & Implementation to secure your compliance
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Transition

Transition Management - Pharmaceutical Industry

  • The proposed transition managers are all from the pool of our aseptic process experts. They were therefore qualified for their technical skills and experience. They do not therefore perform a simple interim mission but advance your work on site with an expert approach.
  • They can carry out, depending on availability, full-time missions (4-5 days per week) or missions of 2-3 days per week

Operational in a very short time

  • Objectives defined prior to the transition management mission make it possible to propose the most suitable profiles corresponding to the defined scope
  • Being qualified for the mission, the transition manager brings his experience to your needs and is operational very quickly.
  • He provides adapted solutions that have already proven themselves thanks to his outside eyes as a professional in the pharmaceutical industry.
  • Our transition manager can consult our network of experts in order to intervene effectively and as soon as possible
  • It transfers its skills, know-how and experience to your teams. This training will continue after the end of the transition mission.


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