Combination Product Expertise And Target Market Knowledge Secure Fast-Track Review

To better express and understand the full potential of its product, an international company realized that it would need a partner with regulatory and strategic development expertise to get it to commercialization. The product, a catheter tailored to meet the specific needs of a drug designed to cure an organ cancer, needed FDA approval to move on to the next step.

Before presenting how the product could substantially increase the quality of life for patients and reduce overall treatment costs compared to the current standard of care, the company met with the Premier Consulting team.

Learn about the importance of understanding the target market and the regulatory requirements that govern combination products and how Premier Consulting used these elements to achieve commercial success.