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Therapeutic Expertise
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505(b)(2) Clinical Development Programs

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.

  • Candidate identification
  • Feasibility assessment
  • Assessing regulatory pathway
  • Development and execution of clinical development plan
  • Market access, securing code reimbursement and payment

  • Pre IND, IND, NDA, and ANDA preparation
  • Submission and Maintenance

Nonclinical strategy and study design, CRO identification & qualification, Project Management

Clinical Study Planning and execution

Orphan Drug Designation