Regulatory IT Services

Digital Services

Overview

Syntel provides global regulatory IT services and lifecycle management for all phases of the pharmaceutical and medical device development process.

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Offerings

  • Clinical trial applications
  • Medical writing and dossier preparation
  • Change control management
  • Compliance and business risk consulting
  • Quality management and quality control
  • Regulatory and compliance management
  • Post-approval lifecycle management
  • Submission and data management

 

The Syntel Advantage

 
  • Expert team to manage adherence to regulatory requirements for pharmaceutical and medical product development programs
  • Consolidated framework for end-to-end pharmaceutical regulatory affairs, including dossier preparation, submission review and filing
  • Agile methodology to quickly implement revised plans as regulatory requirements change

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