Life Sciences

ABOUT LIFE SCIENCES

ALTEN has been delivering first-class services in Life Sciences for more than 15 years. From R&D, supporting manufacturing processes and technologies, through engineering for commercial facilities, to ensuring compliance through the value chain, we accompany our customers and strive to deliver value, provide flexibility, and ensure quality. Thanks to our knowledge of the industry, the technology we use, our expertise in the process and in various domains, such as regulatory & compliance experience, we have been able to set ourselves as experts and key partners for our various clients, from startups, to mid-size CDMOs, pharmaceutical, and biotech companies.

CLIENTS

Service Areas

MANUFACTURING

At ALTEN, thanks to our committed engineers, we are able to support our clients on a wide range of processes, including biotechnology, cosmeceuticals, biomedical technologies, nutraceuticals, food processing, pharmaceuticals, or medical devices. We accompany them through the whole value chain, taking care of supply and planning, supporting digital transformation towards manufacturing 4.0, and increasing operational excellence, no matter the equipment or technology involved. 

COMPETENCES

Manufacturing (Production, Packaging)
Supply Chain, Logistics and Purchasing
Manufacturing 4.0
Lean 6 sigma and Continuous Improvement

ENGINEERING AND R&D

Our experts guarantee adequate change management by building, running, and optimising projects and programmes for our partners. At ALTEN, we are present through the whole process: installation, maintenance, validation, and qualification, to ensure availability and efficiency at all times. We intervene in various facilities, such as laboratory, production, or utilities, with technology and equipment expertise.

COMPETENCES

R&D
Tech Transfer, NPI, NPD
Engineering (Maintenance & Commissioning)
Validation (Qualification & Validation, CSV, V&V)
Engineering 4.0
PMO, PM, Change Management

COMPLIANCE

The Life Sciences industry, being one of the most highly regulated ones (due to the impact medicines, treatments, and devices can have on patients), it is our duty to put compliance as one of our topmost priorities. At ALTEN, we are set on having extensive expertise and experience in quality and regulatory affairs. We maneuver all the regulations and guidance (ISO, FDA, EMA, cGxP, ICH), supporting operations, systems and transformation projects, securing compliance and adequate risk management – making us a key partner for many companies trusting us with the managing of their quality systems.

COMPETENCES

Quality Assurance
Quality Control
Regulatory Affairs
Quality 4.0

CRO

Aixial Group, part of ALTEN, has grown into one of the world’s leading global Clinical Research Organisations. Aixial provides the clinical development capabilities and integrated consulting expertise needed to streamline development at every step, in a faster and more cost-effective way. From decentralised clinical trials to regulatory consulting services, as well as leveraging real-world insights, our therapeutic, technical, and functional ability is underpinned by a patient-first culture, as an embedded value.