New Product Registration

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).


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