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Post-Approval Product Lifecycle Management

Ensure post-approval dossier compliance with global product lifecycle management of marketing applications

 
For four decades, Cardinal Health Specialty Solutions has provided global regulatory consulting and guidance to help clients achieve the scientific, regulatory and product performance goals for their pre- and post-approval regulatory needs. We offer services through a partner-based, milestone-driven business model aimed at providing support for post-approval product lifecycle management of marketing applications. Our partnering model is highly flexible, allowing it to be easily customized to individual client requirements.

The Cardinal Health difference

Our team’s ability to provide expert technical and regulatory consulting, as well as scientific authoring of dossiers, sets Cardinal Health apart from other consulting companies.

  • Work independently or under the direction of a member of your management team
  • Help to establish your regulatory strategy for maintaining consistent submissions
  • Interact with your manufacturing group(s) to evaluate deviations and change controls for global regulatory impact
  • Provide submission-ready documents prepared according to your specific internal requirements or prepared using one of our established templates

Our team’s ability to provide expert technical and regulatory consulting, as well as scientific authoring of dossiers, sets Cardinal Health apart from other consulting companies.

Christine Bentley

Christine Bentley

Managing Director, Chemistry, Manufacturing and Controls

Brian Cudney, MBA, CSSBB

Brian Cudney, MBA, CSSBB

Director, Chemistry, Manufacturing and Controls

Investigational and Marketing Application Services

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