Biologics Consulting Services

The path to approval can be complex. Rely on our biologics experts to help you navigate it, faster.

As innovation in immunotherapy and genomics continues to grow, the number of biologics approved by the FDA has quadrupled over the past several years. The challenges related to the development and manufacturing of biologics are significant, so it’s critical to select a regulatory partner who is experienced in navigating this complex landscape to ensure a smooth path to approval.

Complete regulatory resources from the biologics experts

Cardinal Health Regulatory Services offers a complete suite of regulatory resources to support the development of biologic products. Over the past two years, we have worked on more than 10 biologic license applications (BLAs) and have provided significant support on seven Human Cellular and Tissue Product (HCT/P) applications. We can help evaluate the status of product development, create product development plans, provide guidance and support for FDA meetings, and manage IND/BLA submissions.

Our suite of biologic product development services includes

  • Preparation/review of clinical and nonclinical protocols
  • Regulatory guidance related to quality attributes such as potency and identity
  • Development/assessment of GMP manufacturing process
  • Current Good Tissue Practice compliance
  • Tissue facility registration
  • Preparation of requests for designations to determine appropriate jurisdiction/development pathway
  • Preparation of orphan drug designations
  • Preparation of documentation to support FDA Expedited Programs
  • Due diligence assessments
  • Pre/pre-IND meeting (nonclinical) support: preparation, submission, and leadership
  • Type A, B, and C FDA meeting support: preparation, submission, and leadership
  • Lifecycle management of IND/BLA

Contact our experts today

Put our proven biologics development expertise to work for you. Contact us today to learn how we can get your therapy in the hands of patients, faster.

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