sector
Pharmaceuticals
Innovation for healthcare
The pharmaceutical industry ensures the quality, safety and distribution of drugs. agap2 works in the following areas :
- Pharmaceuticals
- Biotechnology
- Fine chemicals
- Cosmetics
Areas of expertise
- Engineering and New works : Project management, Revamping, HVAC, Infrastructure, Equipment, Construction site supervision, specifications management, writing the URS
- Industrialisation, Qualification and Validation : Production, Installation, Equipment qualification, Validation of IT Systems
- Quality : BPF, GMP, BPC, BPD, BPL, ISO 9001, SMQ, VMQ, VSI, GAMP5, Appendix 11, 21 CFR part11, Audit, training, Analytical methods
- Regulatory affairs : Registration/Submission FDA Europe, China, Variation, Module 1, Module 3, CMC, Change Control, Labelling
- Supply Chain et Gestion de projet : Serialisation, Packaging, Continuous improvement, Lean Manufacturing, Flow management
Project 1
Aguettant
Implementation of the serialisation process
Context : Serialisation is a legal obligation requiring all pharmaceutical laboratories to identify each item of drug packaging in a standardised way and to record this information in databases that will guarantee the traceability of the drugs.
agap2 expertise : Aymeric is a Robotics and Industrial IT Engineer and supports Aguettant in implementing serialisation.
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Industry projects
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Novo Nordisk
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Sanofi
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Boehringer Ingelheim
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Genzyme
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Octapharma
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GSK
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Boiron
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LFB
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Aguettant Essential
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Servier
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Johnson & Johnson
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Guerbet
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Novartis
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MERCK Serano
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MSD
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