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If you’re looking to reposition an existing product or expand your portfolio with a differentiated product, the 505(b)(2) approval pathway is your best way forward. Camargo is the most experienced global strategist specializing in 505(b)(2) development from concept to commercialization.

Experience is about more than having done something, it’s about having achieved something. That’s what sets the team at Camargo apart. Having filed with every drug division of the FDA’s Office of New Drugs numerous times, our team delivers extensive therapeutic expertise and routinely holds three to six pre-IND meetings a month. In fact, our team includes former FDA leaders and has guided more than 200 FDA approvals. And while we’ve had hundreds of successful meetings, it’s the 95+ percent FDA concurrence rate for fulfilling NDA approval requirements that speaks to our ability to devise and execute effective strategies.

Ready to identify and develop viable products? Put your product on the path to approval, and your business on the path to profitability. Take your first step.

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