TGen Drug Development gets skills in drug manufacturing and quality control; Rondaxe receives access to TD2's expertise in clinical trials and regulatory navigation
TGen Drug Development (TD2) and Rondaxe Enterprises today announced a strategic alliance that will help emerging companies speed new high-quality treatments to cancer patients.
Rondaxe, a drug development consulting company in Syracuse, N.Y., helps emerging pharmaceutical and biotechnology companies navigate through all phases of the drug development and commercialization process. The company specializes in drug chemistry, manufacturing and controls (CMC), quality assurance and control, regulatory affairs and virtual business development.
TD2, a non-profit Scottsdale subsidiary of the Phoenix-based Translational Genomic Research Institute (TGen), specializes in guiding drug companies through the complexities of setting up and conducting clinical trials, and moving promising drug candidates through the federal review process of the U.S. Food and Drug Administration.
"We are excited to work with Rondaxe, since effective CMC management is key to the successful application and approval processes of the FDA, and moving new anti-cancer treatments to market where they can provide patient benefit," said Dr. Stephen Gately, President and Chief Science Officer at TD2.
Jeffrey M. Evans, Ph.D., co-founder and managing partner of Rondaxe, said, "Our clients will benefit measurably from the 'TD2 Solution' by receiving clear clinical and regulatory development path guidance and service support."