505 (b)(2) studies

The 505 (b)(2) studies also known as bridging studies are highly significant as they help in avoiding unnecessary duplication of studies that have been conducted on a previously approved drug. A 505(b)(2) New Drug Application incorporates not only entire safety and effectiveness reports, but also has some information on the active ingredient that comes from studies which are previously conducted and not by the NDA. This facilitates a faster approval owing to cost and time optimization.

At VIMTA, we perform 505 (b)(2) studies, leveraging the available safety and efficacy data of the active ingredient, thus helping our clients fast track the product to market. We have successfully conducted various 505 (b)(2) studies for tablets versus capsules, tablet versus solution and many more.