Why Aexelar
We offer a complete suite of regulatory strategy and submissions development and medical information services. We are honored to share that all of the NDA submissions, that we developed/guided the regulatory strategies for, have received first cycle approvals by the US Food and Drug Administration and other health authorities.
We are passionate about helping clients develop and execute robust regulatory strategies, registration dossiers (NDAs, NDSs, MAAs) and negotiate drug product approvals.