Regulatory Affairs

Digital Services

Overview

Complying with global regulatory regimes is expensive and cumbersome, with stringent new regulations rolled out every year. Atos|Syntel has the infrastructure and experience to help life sciences companies maintain and manage compliance with a well-defined framework for system validation, and secure management of electronic records and signatures.

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Offerings

  • End-to-end document management
  • Publishing and submission services
  • Audits and validations
  • Computer system validation services
  • Labelling services

 

The Atos|Syntel Advantage

 
  • Integrated end-to-end record management and archival process
  • Experience in operations management in multiple geographies
  • Submission and audit-ready platforms
  • Dedicated CoE for regulatory affairs and compliance
  • Labelling conversion capabilities, including documentation review and translation
  • Expertise with marketing assets like brochures, newsletters, websites, motion graphics and rich media

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