Some of the Benefits

As a member of The 505(b)(2) Platform you will:

Gain access to best practice Information

Our leadership and members contribute and develop some of the best approaches to developing a 505(b)(2) product. As a member you  will have access to this information and much more that can help you better understand 505(b)(2) product development, regulatory strategies, and market launch. 

Access to partnering Opportunities

Members gain access to partnering opportunities that may open new business development for your company to pursue. Development companies can partner with dosage form exerts and manufacturers can connect with marketers, etc 

help determine the Advocacy and educational efforts of the Platform

Platform members gain the ability to suggest and vote on the efforts undertaken by The Platform including future advocacy efforts. ​

Gain access to a marketplace of Verified 505(b)(2) Suppliers and consultants

Many suppliers believe that a 505(b)(2) is the same as a 505(b)(1) but nothing could be further from the truth. Platform members gain access to a verified marketplace of solution providers who have value-added medicines experience to assist them with their development and commercialization efforts.

Gain Free Access to in depth 505(b)(2) Information and analysis

The 505(b)(2) leadership have years of experience handling 505(b)(2) development, regulatory, and commercialization. Members of The Platform network gain access to the leadership and other members that can help.

Learn about bringing 505(b)(2)'s to market

Bringing a 505(b)(2) product to market is a tricky issue and needs some deep planning. Starting with a value proposition to understanding the access hurdles and managing the financial/pricing issues 505(b)(2) commercialization is complex. As a member you gain access to experts in 505(b)(2) commercialization and solution providers that have verified experience.

Increase your Opportunities

As a 505(b)(2) Platform member you become the first to know when opportunities arise. Be the first to know about advocacy efforts, new regulatory actions, and legal actions that are related to 505(b)(2) products.