Mikel Alberdi, MPH, RAC

VP of Regulatory Affairs

Mikel has vast knowledge and experience with FDA regulations and compliance relating to drugs, biologicals, devices and combination products. He has 15 years of regulatory affairs experience including preparation of FDA submissions (NDA, 505(b)(2) NDA, ANDA, IND), Pre-IND, Pre-NDA, End-of-Phase submissions and facilitation of meetings with FDA.

His experience also spans eCTD, Amendments, Supplements, Annual Reports, Drug Master Files, Citizen Petitions, clinical and nonclinical study design and interpretation, finished Product/ API site audits and CRO qualifications, cGMP audits (foreign and domestic).

He also manages our electronic submission gateway (ESG), eCTD compilation, review, validation and submission to FDA, as well as electronic Drug Establishment Registrations and Product Listings.