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Since 1976, Cardinal Health Regulatory Sciences has been partnering with pharmaceutical, biotechnology and medical device companies at all phases of development to provide efficient regulatory and product development consulting services. Our regulatory strategies and services are designed to help companies obtain global product approval and maintain filings throughout the entire product lifecycle.

With industry and FDA training, each one of our more than 130 in-house consultants has an average of more than 15 years of industry experience. Our regulatory experts have had successful interactions with global regulatory agencies and have worked with every review division of the FDA. The Cardinal Health team has provided support for more than 100 New Drug Application (NDA), Biologic License Application (BLA) and Abbreviated New Drug Application (ANDA) approvals and has provided support for more than 500 Investigational New Drug (IND) applications. Our team has more than 500 approved products under maintenance and has provided drug development services for new drugs in all major therapeutic areas.

We provided a wide range of consulting services required to obtain approval for drugs, biologics and medical devices for the US and global markets. We help our clients increase the financial returns on their investments through the design and implementation of efficient scientific and regulatory strategies.

Services Offered:
• Drug development consulting
• Preclinical development consulting
• Clinical development consulting
• Chemistry, manufacturing, and controls (CMC) consulting
• Medical writing
• Promotional materials consulting (OPDP)
• Global regulatory dossier preparation
• Regulatory publishing services
• State licensing and registration
• Compliance audit services (CGMP, GLP, GCP, GXP, QSR, and SOPs)
• Customized training courses

Trey Putnam
Vice President and General Manager at Cardinal Health Regulatory Sciences

Chris Kavlick
Director, Business Development at Cardinal Health Regulatory Sciences