Regulatory Consulting Services

Accurate. Accelerated. Approved.

Our Regulatory Experts

Drug Development Services

Cardinal Health designs and implements efficient drug development plans to reduce development time and costs.

Global Regulatory Affairs

Cardinal Health provides regulatory affairs services to meet the requirements of global regulatory agencies.

FDA Expedited Programs

Cardinal Health provides services that will assist you in receiving one or more of FDA’s expedited programs to help you obtain marketing approval faster.

Clinical Research

Cardinal Health provides clinical research and clinical operations services to facilitate rapid product development.

Chemistry, Manufacturing and Controls

Cardinal Health provides CMC consulting services to facilitate the preparation of regulatory submissions.

Regulatory Publishing

Cardinal Health has four decades of experience preparing, reviewing and publishing regulatory submissions.

State Licensing

Cardinal Health helps you obtain state licenses required for distribution of your commercial products.

Meet the Experts

Cardinal Health has a diversified team of experts in all aspects of regulatory consulting for product development.

Animal Health Services

Cardinal Health provides animal health product development services to help companies obtain and maintain regulatory approval.

Orphan Products

Cardinal Health helps companies obtain orphan drug designation and achieve successful development and commercialization of orphan drugs.

Nonclinical Consulting

Cardinal Health provides nonclinical research and consulting services to facilitate rapid product development.

Medical Writing

Cardinal Health medical writers understand and interpret the scientific aspects of your development program.

Pharmaceutical Compliance

Cardinal Health provides compliance services required to meet global regulations for product development.

Product Lifecycle Management

Cardinal Health provides post-approval lifecycle management services to ensure global regulatory compliance.

Regulatory Training

Cardinal Health regulatory workshops provide the information and resources needed for global product approval.

Cardinal Health Brochure

Regulatory Outsourcing