The Benefits

The 505(b)(2) Platform and its members can help:

identify ​Product Opportunities

Our leadership and members can help you identify product enhancements that can make your existing products 505(b)(2) opportunities with the highest potential for success. 

define the Market

We can help you research and identify market opportunities, explore adjacent market opportunities and understand the market dynamics. It is important to analyze the state of the market, its current demand, and the potential that it provides to a new product.  We are here to help you consider the entire situation and calculate the real value of a potential product.​

develop Intellectual Property

Platform members have a forum to discuss issues relating to potential IP hurdles and how to address them as well as how to obtain IP to protect their products. All of which is critical to the successful launch of a 505(b)(2) product. ​

Regulatory applications and Submissions

The 505(b)(2) Platform leadership and members have years of experience handling 505(b)(2) regulatory strategy and submissions. Members of The Platform network can help you strategize the best regulatory approach for your product and the proper reference product(s). Other members can create the various regulatory communications and submit them into the U.S. FDA for review.

Regulatory compliance

Our members can help you ensure you are compliant with all the regulations. All healthcare products companies doing business in the U.S. must comply with the laws of the U.S. and follow the relevant regulations, guidelines and specifications and avoiding legal punishment which include federal fines.

Value Identification

505(b)(2) products need a value proposition. A value proposition is a key element of developing any healthcare product to be marketed in the U.S. The value proposition identifies clear, measurable and demonstrable benefits consumers get when buying a particular product or service. Our members can help develop a value proposition which can lead to a competitive advantage in the marketplace.

Marketing Strategy Development & Implementation

The U.S. healthcare market is complex and ever changing. Our expert members can help outline an overall game plan to create awareness of your product among stakeholders. Your product marketing strategy will further develop the value proposition, identifying key marketing messages and how, when and where to communicate those messages to the target audience.

Expert ContRacting

Each service and individual member (non-company affiliated) of The 505(b)(2) Platform undergo a review process to ensure that they have 505(b)(2) experience and a validated area of expertise. Through our qualified service member organization’s you can easily identify qualified expertise for any contracting/consulting need you might have along the development-commercialization pathway. If you have very specific expertise needs, we can also assist by conducting a proactive, custom search based on the specific case needs