Regulatory Affairs

Global pharmaceutical companies are facing an increasingly onerous regulatory regime across different phases of their product life cycle from drug discovery to marketing authorization.

Our expert regulatory affairs team is second to none. Through multidisciplinary expertise, we can ensure you to:

  • Reduce costs
  • Accelerate the time it takes to get approved
  • Improve your procedures and process

Our team capabilities include:

  • Periodic and Annual Report Preparation
  • Chemistry, Manufacturing and Controls
  • Electronic Submissions (eCTD)
  • Sponsor / FDA Meetings
  • Regulatory Life-Cycle Management
  • Worldwide Support

Get in touch today to learn more.