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.