The Center for Advanced Regulatory Analysis (CARA) provides regulatory training, short courses and staff consulting in the area of biopharmaceutical protein characterization. We also provide analytical services based on a large array of state-of-the-art instrumentation and world class technical staff.
CARA plays a critical role in ensuring drug safety and quality for consumers by being a center that focuses on the regulatory analysis of biotechnology products, including biosimilars, and will serve as a resource to those pharmaceutical companies developing new drugs.
CARA also evaluates the capabilities of existing analytical technologies on behalf of tool providers by conducting cross-platform evaluation. The Center participates in the creation of new or improved analytical technologies and provides independent analyses of drugs produced in the U.S. and overseas and also conducts comprehensive characterization studies of complex glycoproteins.
Services provided by CARA include implementation of analytical technology through collaborative service agreements. For instance, the Center conducts comparability studies of multiple glycoprotein batches; characterization data needed for the CTD Module 3 filing.
CARA’s staff is comprised of world-class experts and thought leaders in their specialized fields. They bring a level and breath of expertise rarely found in the private sector.