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Identifying the Product

Format: PDF file | Document type: White / Technical Paper

When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and lower risk.


Camargo Pharmaceutical Services offers a clear process from concept through commercialization to identify products with documented market differentiation:

  • Selection criteria
  • Identify, assess and rank unmet needs
  • Defend value and maximize investment
  • Narrow candidates
  • 505(b)(2) development plan
  • Product case histories


For differentiated product benefits, 505(b)(2) is not just a regulatory platform — it’s a different animal.

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