Dr. Nic Scalfarotto

Dr. Scalfarotto is responsible for Regulatory Strategy for Aquity Associates. His broad expertise in global regulatory, strategic development supports Aquity’s extensive range of expertise and its synergistic vision of offering discreet and integrated expert consulting services to the life sciences industries.

He has held executive roles in a range of bio-pharmaceutical and CRO settings covering clinical research, regulatory affairs program management, and start-ups. Dr. Scalfarotto’s global experience encompasses oversight of interactions with FDA, EMA, Health Canada, PMDA, ANVISA TGA, among others, covering all stages of development and a broad spectrum of therapeutic indications for small molecules, novel biologics, biosimilars, bio-betters, follow-on biologics, combination products, and devices. Additionally, he established a due diligence function for regulatory within a major pharmaceutical company publishing on the topic and chairing expert panels on the subject.

In addition to his expertise in regulatory science, Dr. Scalfarotto has held general management responsibilities and was responsible for the creation of two start-ups which included strategic and tactical planning, finance, operations, business development, regulatory affairs, quality assurance, information systems, facilities management, and planning.

Dr. Scalfarotto holds an undergraduate degree in Biology from Seton Hall University, a Veterinary Degree from the University of Bologna, and has completed graduate studies at the University of Grenoble.

nscalfarotto@aquityassociates.com
(203) 676-1101