Regulatory Affairs

Digital Services

Overview

Complying with global regulatory regimes is expensive and cumbersome, with stringent new regulations rolled out every year. 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 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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