Getting a new drug product approved is a major challenge involving many key elements. At FreeThink, we are specialists in shelf-life determinations. We help both small and large clients make more-informed decisions earlier in the process, and conduct cGMP stability studies for registration at our Connecticut-based laboratories. FreeThink has the expertise to get your new product through the registration process, while meeting all of the regulatory rigor required.
ASAPprime® software and ASAPprime® stability modeling studies can be conducted by our clients or at FreeThink’s laboratories, and are used in support of registration filings. In one case, a client used ASAPprime® modeling with only three months of ICH data and was granted a three-year launch shelf-life in the EU (with commitment to ongoing monitoring).