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Regulatory Consulting Services

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

Accurate. Accelerated. Approved.

Every day your therapy sits in the development pipeline costs you money and costs patients the opportunity for treatment. At Cardinal Health, we know how critical it is to get it right the first time at every step of the development process for your pharmaceutical, biotechnology and medical device products. We’ll partner with you to devise the best pathway for your therapy from inspiration to marketing product approval and beyond.
For four decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to market quickly. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on your research investments. We provide efficient scientific and regulatory consulting services throughout the full product lifecycle to help ensure the continued success of your product post-approval.

Our Regulatory Experts

Each one of our 150+ scientific and regulatory consultants has an average of more than 15 years of industry and FDA experience and training. Our regulatory experts have had successful interactions with global regulatory agencies and have worked with every review division of the FDA. Cardinal Health 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 drug development services for new drugs in all major therapeutic areas. We leverage the extensive knowledge and expertise gained from our experiences with global clients to continue improving upon our services and internal processes.

Regulatory Insights Portal

Streamline the path to approval and market access with actionable regulatory insights.

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 Services

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 Drug and Device Development

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

Making regulatory outsourcing effective for biopharma and medical device companies