A selection of expert and interim management assignments carried out by Axys-Network. Clients are not named.
Context: an Indian biotech manufacturer produces an injectable product on behalf of a major US group, for the US market. Its aseptic practices have to meet FDA expectations.
Intervention: 5 days of on-site expertise to improve aseptic practices, followed by on-site training of 200 people involved in manufacturing.
Result: the products are marketed in the United States.
See the Manufacturing page →Context: following a difficult ANSM inspection, a French laboratory had to bring its site back into compliance.
Intervention: 4 Axys-Network experts deployed for 3 months alongside the site teams.
Result: the commitments made to the ANSM were in place on site before the final assessment. A global remediation plan was then drawn up to prepare the group's other sites.
Context: a Japanese laboratory wanted to export a Blow-Fill-Seal product to the European market and reduce its dependence on European contract manufacturers.
Intervention: audit of the manufacturing site against European requirements, and recommendations to secure the project.
Result: the laboratory now exports its product to Europe.
See the Quality page →Context: construction in Europe of a large plant for the manufacture of biotech products.
Intervention: many Axys-Network interim managers deployed over several years to support the project.
Result: the project is being finalised, on schedule.
See the Interim management page →Context: a major French pharmaceutical group was investing for the first time in the manufacture of biotech medicines.
Intervention: owner's engineering support for a €750 million investment, through to plant handover. Up to 6 Axys-Network experts on site held the key roles:
Our experts covered every area of the plant, from pharmaceutical and non-pharmaceutical utilities to aseptic processes.
Result: the plant was handed over in routine production.
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