Guiding your company from gap to compliance

Life Sciences is a highly regulated industry that prioritizes product quality and patient safety. The development of new typically takes an average of fifteen years, while patent protection for these products is often limited to twenty years. Regulatory authorities closely monitor the entire process from development to manufacturing. Noncompliance can result in delays in market approval or even product recall in cases of serious infringements.

Compliance with regulations is therefore of the utmost importance for companies in the Life Sciences sector.

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To achieve results within the often-changing regulatory framework, we help companies in Life Sciences to comply with all applicable regulatory requirements. Our OASeS framework provides regulatory gap assessments, implementation plans and support in remediation activities.

What we offer:

• Expertise: With a team of over 350 specialists, we possess the necessary knowledge and specific expertise in any field of Life Sciences.
• Synergy with other Business Areas: The capability to collaborate internally with other Sopra Steria Business Units, such as Cybersecurity and Data Science, enables us to provide holistic solutions that address multiple aspects of compliance requirements.
• Assets: Our OASeS toolkit, which includes ready to use checklists and templates, guarantees a streamlined audit and assessment process.
• Efficiency and Time-to-Market: We can identify and mitigate gaps quickly and efficiently. This results in shorter time-to-market for your products or services by reducing the costs of noncompliance.
• Comprehensive Coverage: We offer audits and assessments in a wide range of areas related to production, laboratory and computerized systems.
• Full-service Solution: Our service extends beyond short term compliance activities, enabling Sopra Steria to be a long-term business partner through a service solution.

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