Your First Step Toward 505(b)(2) Approval
Camargo’s feasibility assessment will set the cornerstone of your cost-effective development plan with a disciplined approach to evaluating the scientific, medical, regulatory and commercial aspects of your product development opportunities to make correct go/no-go decisions.
What clinical trials or other data will be required to gain approval? Can development be expedited? Would exclusive marketing rights (“exclusivity”) be available? What distinguishing information can be presented on the labeling for eventual promotional activity?
Is there a viable market for the product? What is the potential for future competition or substitution? What is needed to ensure reimbursement? What is the optimal pricing?
Does the science make sense? For instance, is the formulation stable and readily prepared? Is manufacturing scalable? Are active and inactive ingredients available and affordable?
Does the product have a clear niche in the medical specialty? Is it effective for solving a unique problem or solving a problem in a unique way? Does it present an acceptable risk/benefit? Is there evidence the product would be appealing to the proposed patient population?
Armed with the intelligence our feasibility assessment uncovers, Camargo creates a robust, systematic development plan — there’s no better partner for comprehensive 505(b)(2) development than Camargo. Feasibility is a critical first step in the race to drug approval, and — with reach spanning 25+ countries — Camargo will lead you to success no matter where you embark.
No Other Partner Specializes in Assessing and Executing Every Aspect of 505(b)(2) Product Viability.
Read more about how we identify viable products.
The Expert By Your Side
While 505(b)(2) can accelerate approval for a wide range of products, early assessment and planning are essential to maximize the value of development opportunities. Camargo has extensive experience in bringing all marketed types and forms of products to approval.