About Us

The RRI Group of Companies has found, in the course of our consulting activities, that Generic and Specialty Pharmaceutical companies are constantly searching for new products to strengthen their portfolios. They are especially interested in gaining FDA approval for these products with limited pharmacokinetic or clinical studies, and without long regulatory reviews.

Whether your plans call for an ANDA, including PEPFAR's, or an NDA, particularly 505(b)(2)'s, The RRI Group of Companies can best serve your drug development requirements. With headquarters in the USA and consultants worldwide, we work with clients, regulatory agencies, CRO's, and IRB's across the globe. To assist our clients in developing candidates, we employ a number of strategies: For example, we are particularly adept at identifying new 505(b)(2) opportunities, and then realizing the opportunity for our clients by leading them through the process of pre-IND meetings, IND and NDA submission and product approval by the FDA.

As another example, The RRI Group of Companies has developed a list of Abandoned ANDAs and NDAs. After initial product selection by the client, we provide product evaluation, transfer, oversight and regulatory services leading to the submission of the CBE30 site transfer supplement. The CBE30 can provide a very rapid entry to market. Total time between product selection to initial distribution of your product can be less than a year.