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Global Regulatory Affairs Consulting Services

A customized approach to strategic product development — meet the complex requirements of global regulatory agencies

Regulatory affairs expertise

The regulatory affairs experts at Cardinal Health have experience in all major therapeutic areas and have had successful interactions with all regulatory divisions within the FDA and several other global regulatory agencies. Our team of industry-trained scientific and regulatory consultants will support your product throughout the entire development continuum, from concept and strategic development, to proof-of-concept and market approval, to post-approval maintenance. We provide regulatory affairs solutions for full product lifecycle management. Our regulatory expertise also includes solutions to help clients navigate the complex requirements for orphan drug development and the FDA expedited programs.

Wayne Vallee, RPh, MBA, RAC

Wayne Vallee, RPh, MBA, RAC

Investigational and Marketing Application Services

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