Life Sciences

ABOUT LIFE SCIENCES

In the last 15 years, ALTEN has become an essential partner for the major players in the Life Sciences market for a lot of mid-size CDMOs and pharmaceutical and biotech companies. We deliver first-class services, from engineering for Research & Development and commercial facilities, through supporting manufacturing processes and technologies, to ensuring compliance throughout the value chain. We always strive to deliver value, ensure scalability and provide flexibility thanks to our knowledge of the industry, our technologies & process expertise, and our regulatory & compliance experience.

We are delivering high added-value services with increased commitment, in complex technologies activities, such as biotech, the pharmaceutical industry, vaccines production (i.e. covid, chikungunya), chemicals (scents and flavors) or Industry 4.0.

Service Areas

Manufacturing

MANUFACTURING

We bring our expertise to our clients throughout the whole value chain: from production, facilities, laboratories, and supply chain to packing, labeling, and visual inspection. We support a wide range of processes in various sectors (pharmaceuticals, biotechnology, medical devices, biomedical technologies, nutraceuticals, cosmeceuticals, food processing) and we contribute to operational excellence and transformation towards manufacturing 4.0.

COMPETENCES

Manufacturing (production, packaging)
Supply Chain, logistics, and purchasing
Manufacturing 4.0
Lean 6 Sigma and continuous improvement

Engineering and R&D

ENGINEERING AND R&D

Our expertise applies to a wide range of facilities (laboratory, production, utilities, etc.). We ensure asset availability and efficiency, carrying out installation, maintenance, validation, and qualification. We are able to support our clients in building, running, and optimizing projects and programs, guaranteeing adequate change management.

COMPETENCES

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

Compliance

COMPLIANCE

The Life Sciences industry is one of the most highly regulated industries: medicines, treatments, and devices have a big impact on the lives of patients. Compliance is therefore one of today’s utmost priority. ALTEN has extensive expertise and experience in quality and regulatory affairs.

We manage all the regulations and guidance (ISO, FDA, EMA, cGxP, ICH), supporting operations, systems, and transformation projects, securing compliance and adequate risk management

ALTEN is today a key partner for multiple companies, managing entire sections of their quality systems. ALTEN intervenes end to end to ensure clients’ inspection readiness, following the steps below or focusing on a specific part.

COMPETENCES

Quality Assurance
Quality Control
Regulatory Affairs
Quality 4.0

Clinical Research Organization (CRO)

CLINICAL RESEARCH ORGANIZATION (CRO)

We bring our expertise to our clients through the whole value chain: from production, facilities, laboratories, and supply chain to packing, labeling, and visual inspection. We support a wide range of processes in various sectors (pharmaceuticals, biotechnology, medical devices, biomedical technologies, nutraceuticals, cosmeceuticals, food processing) and we contribute to operational excellence and transformation towards manufacturing 4.0.