bd@cbcc.global
505(b)(2) Clinical Development Programs
services
Expertise in helping clients and their programs navigate the 505(b)(2) drug development pathway
Supporting 505(b)(2) programs from conceptualization, navigating Pre-IND conversations and meetings, and seamless execution of multi-country trials.
Product Concept Evaluation
Regulatory Support
Nonclinical strategy and study design, CRO identification & qualification, Project Management
Clinical Study Planning and execution
Orphan Drug Designation
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