Regulatory Consulting Services
Accurate. Accelerated. Approved

Cardinal Health Regulatory Sciences delivers proven regulatory consulting expertise to help you obtain global product approval and maintain filings throughout the entire product lifecycle.


Experience you can trust

Unmatched regulatory consulting expertise. Every day your therapy sits in the development pipeline, you lose money, and patients lose the opportunity for treatment. That's why it's critical to get your regulatory strategy right the first time, every step of the way.

Cardinal Health Regulatory Sciences will partner with you to develop the best regulatory pathway for your product, through every stage of its lifecycle. Our regulatory strategies can reduce the risk of failure and increase your speed to market.

Tap into our various solutions, including:

  • CMC – Chemistry, manufacturing and controls consulting services help guide your regulatory submissions
  • Scientific/Medical Writing Services – Our dedicated writing team helps to accurately tell your drug development story
  • Regulatory Submissions Operations – Customized solutions for eCTD publishing and eCTD submission
  • Compliance – Services to help meet global regulations for product development.
  • FTE Models – Pharma product life cycle management for post-approval compliance