In vitro BA/BE Testing
Exemplar is regularly in touch with FDA regarding the interpretation of FDA guidances that control various aspects of both CMC and BA/BE requirements.
Regulatory Support
Exemplar's expertise can assist in the process of choosing the correct regulatory pathway for your product including specific issues related to the pharmaceutical medical device and biotechnology industries. Our staff is capable of assisting in the preparation of IND, NDA, ANDA and like applications.