The health crisis requires the mass marketing and production of COVID-related vaccines and treatments in record time.

At the same time, the ageing of the population and budgetary constraints are leading the authorities to put pressure on the pharmaceutical industry to lower the price of medicines.

To achieve these cost and scale objectives, the pharmaceutical industry is accelerating its transformation (outsourcing of R&D and production-CDMO), digitizing its production plants and securing its complex supply chains.

Furthermore, in order to stay in the technological race, the giants of the sector are pursuing acquisitions in the fields of Biotech and AI.

Functional sectors

covered by ALTEN

Manufacturing (Quality Assurance, Qualification, Validation, CSV)

Manufacturing (Quality Assurance, Qualification, Validation, CSV)

Design of medical devices (classes I to III)

Design of medical devices (classes I to III)

Regulatory Affairs and Pharmacovigilance

Regulatory Affairs and Pharmacovigilance

Business transformation and digital services

Business transformation and digital services


In order to be able to launch large-scale clinical trials (phase 3) of a new vaccine, one of the ten international pharmaceutical industry giants has invested in the construction of a new production site in Belgium. ALTEN has been entrusted with the responsibility of qualifying equipment performance (PQ) and drafting the operating instructions.

Certain cosmetic products are considered as OTC (Over The Counter Drugs) in the United States. A prestigious luxury French brand contacted CADUCEUM (specialist subsidiary of the ALTEN group) to bring its facilities into compliance with FDA (Food and Drug Administration) requirements, which is an essential prerequisite for the marketing of its key products.

In the context of developing an immunosuppressive drug for post-renal transplant patient, a global leader in generic and biosimilar medicines outsourced the study of the benefits of the pharmacokinetics profile of its product to AIXIAL (specialized subsidiary of ALTEN Group).

ALTEN has recognized expertise in medical devices and has set up two service centres (Software and Hardware) to support the activities of the R&D centre of one of the world’s leaders in medical imaging. The work carried out by our engineers is in the fields of mammography, interventional radiology and the development of advanced medical imaging applications.

The growing use of digital technologies in pharmaceutical industries, in particular, makes CSV (Computer System Validation), which controls the automated production of drugs, necessary. This validation provides the documented proof that a software application or a computer system will operate continuously and will therefore meet predefined GxP (Good Practice) guidelines.


Pharmaceutical industry

年代anofi, GSK, Roche, Baxter, Servier, Pierre Fabre…

Medical device industry

GE Healthcare, Fresenius, Siemens Healthineers, Philips Healthcare, Air Liquide, Biomerieux, Carmat, Guerbet, BD…

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