505(b)(2) Consulting Services

Experience Is About More Than Having Done Something. It’s About Having Achieved Something.

No other pharmaceutical regulatory consultants are better at identifying and developing viable products via the 505(b)(2) approval pathway. Camargo is the most experienced global strategist specializing in 505(b)(2) development, and there’s no better proof of our ability to devise and execute effective strategies than our track record.

  • 3 to 6 pre-IND meetings a month
  • 200+ FDA NDA and ANDA approvals
  • 95%+ FDA concurrence rate for fulfilling NDA approval requirements
  • Global reach across 25+ countries
  • Excels in providing guidance for the European equivalent of the 505(b)(2) pathway
  • Former FDA team leaders work at Camargo
  • Extensive therapeutic expertise: Camargo has filed with every division of the FDA’s Office of New Drugs numerous times

Our Consulting Clients

Significant changes in small molecule drug development, as well as in the generics drug market, present a growing need for proven regulatory experience to establish and execute approval strategies in the complex 505(b)(2) drug development space. As companies look to secure and sustain commercial relevance, maintaining a diversified product portfolio is key to closing financial gaps. Camargo’s team of pharmaceutical regulatory consultants are passionate about merging business and scientific strategy to make new, enhanced and differentiated therapeutic benefits a reality. To that end, clients rely on Camargo’s pharmaceutical regulatory consulting services to provide 505(b)(2) guidance, assess, identify and substantiate the value of products before making significant development decisions and the attendant investments. Our high client-retention rate, 95+ percent client referral rate and long-term relationships illustrate our capability to work with various clients throughout the development process.

Camargo partners with:

  • Pharmaceutical companies (small to large)
  • Generics companies
  • Venture capitalists and other investors
  • Technology-based active pharmaceutical ingredient (API) producers and contract manufacturing organizations (CMOs)
  • Clinical research organizations

Our Services

Identify Viable Product Opportunities

Develop Viable Products

Regulatory Strategy