Consortium of Pharmaceutical Regulatory Affairs and
Product Development Experts

Aexelar Regulatory Experts, Inc. is a Consortium of Experts with significant knowledge and experience in pharmaceutical product development, registration and approval processes.  Our lead Regulatory Affairs expert, Dr. Sanjay Sehgal, has over 16 years of pharmaceutical industry experience in developing regulatory strategy, preparing submissions including INDs, NDAs, DMFs, NDSs, and global registration dossiers, negotiating product approvals, managing product life-cycle strategies, and providing post-approval regulatory strategy and support.

Prior to founding the Consortium of Regulatory Experts, Sanjay worked as a Senior Director of Regulatory Affairs Chemistry Manufacturing & Controls (CMC) organization at Gilead Sciences, located in Foster City, CA.  Dr. Sehgal has authored or guided the preparation of CMC/Quality sections of over ten New Drug Applications (NDAs), and has negotiated or supported approvals for at least eight NDAs, and several hundred Supplemental NDAs, PAS, CBE-30, CBE, and Annual Reports.

Aexelar's Regulatory Experts provide a broad range of services including preparation of submission documentation for Phases I through III in a variety of therapeutic areas, global submission strategy development, preparation of registration dossiers (NDA, NDS, MAA) in the CTD format, managing product life-cycle strategies, advice and facilitation of FDA-sponsor meetings, due-diligence and evaluation of licensing opportunities, and patents review and evaluation of claims. Additionally, our Consortium of Experts offer expertise in the fields of pharmaceutical and biopharmaceutical formulation development, scale-up, technology transfer, analytical methods development and validation, stability data evaluation and interpretation, pharmacokinetics and clinical regulatory sciences.