ALTEN - Life Science - Information systems - Digitalization

Sectors

LIFE SCIENCE

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

Market Trends and
Challenges

Regulatory Pressure ▶

E-health ▶

Combined Products ▶

Regulatory Pressure

Faced with new regulations, the pharmaceutical and medical device industries have an obligation to comply.

Challenges

Qualify and validate the production and distribution systems impacted

Master the regulatory issues related to the emergence of combined products

Anticipate potential future requirements such as aggregation

E-health

All medical devices are potentially connected. Some are already connected and working through applications that provide health professionals and patients with decision aids, diagnostic possibilities or automatic treatment management. There are many areas of application, including telemedicine, addiction management and chronic disease management.

Challenges

Develop these embedded software in compliance with the regulatory standards of the target market

Prove the regulatory compliance of these products, which is complex due to the requirements related to the status of DM (Medical Device) and the presence of a software

Ensure personal data security and stakeholder trust

Combined Products

A combination product is a health product in which a drug and a medical device are combined. Similarly, to embedded software, innovation and technological progress are making this type of alliance possible more and more and here again the fields of application are numerous. One association that has become commonplace is the combination of hip replacement and antibiotics, which aim to inhibit bacterial adhesion.

Challenges

Master both the normative constraints of DMs and those of drugs, to develop a registrable combined product

Validate the manufacturing process for these combination products

Be able to qualify and classify the combined product to determine the applicable regulatory status, and file for registration

ALTEN Value Proposition

End-to-end Services

The global approach to the sector’s challenges, integrating all regulatory constraints

Expertise Structure

ALTEN integrates into its ecosystem several specialized companies with a high level of expertise (CRO & Pharmacovigilance, Products & Processes, Infrastructures)