About us

Aexelar team brings expertise in regulatory affairs, drug product registration and approval processes, and medical information services. Our experts have decades of experience in regulatory strategy development in the clinical, non-clinical, and chemistry, manufacturing & controls (CMC) areas. We have authored, reviewed and evaluated hundreds of registration dossiers (INDs, IMPDs, CTAs, 505(B)(1) and 505(B)(2) New Drug Applications (NDAs), NDSs, MAAs) and have successfully negotiated multiple drug product approvals with the US Food and Drug Administration, Health Canada and several global health authorities.