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505(b)(2) Expertise

Products on an accelerated path to approval like the 505(b)(2) pathway have the potential for tremendous advantage in today’s competitive market. Building and executing an optimized development plan that avoids expensive delays or do-overs is key to maximizing this advantage. Our multidisciplinary team delivers the expertise to build high-science, creatively bold development strategies, successfully engaging with regulators early and often to drive program success.

Recent projects include:

  • Strategic assessment
  • Product development planning and pre-IND meeting support (request letter submission, package preparation, and attendance)
  • Orphan designation preparation and submission (FDA & EMA)
  • IND preparation and submission
  • NDA preparation and submission

505(b)(2) Insights