Nate DiTommaso, MS

Nate DiTommaso, MS is a Regulatory Affairs Manager and a member of the Syner-G team since the acquisition of Impact Pharmaceutical Services in January 2022. He has over 5 years of Regulatory Affairs experience in the pharmaceutical industry and is well versed in GxP, as well as in the Clinical and Quality operational aspects of drug development.

Nate assists internal and external stakeholders with the preparation, submission, and maintenance of investigational new drug (IND) applications, as well as new drug applications (NDAs) and biologic license applications (BLAs). He provides strategic guidance and regulatory information to product development teams, assist in the authoring and review of regulatory documents to ensure compliance with applicable regulations and guidelines, leads and/or coordinates FDA interactions and communications, and serves as the US Authorized Representative (primary FDA contact) for INDs and NDAs.
Nate has successfully managed large scale documents and submissions for multiple different products in oncology, dermatology, neurology and psychiatry. Nate has experience preparing and reviewing many types of regulatory documents including, IB’s, protocols, CSR’s, orphan drug requests, fast track/breakthrough requests and DSURs/annual reports. He also has experience with preparing strategies and meeting materials (requests and briefing packages) for facilitating discussions with FDA at all phases of development (pre-IND to NDA).

Prior to joining Syner-G, Nate received a bachelor’s degree in Pharmaceutical Sciences at MCPHS University in 2015, master’s degree in Regulatory Affairs and Health Policy at MCPHS University in 2017 and has spent most of his career on the Sponsor side of drug development with focus on R&D, nonclinical studies and early phase clinical development (phase 1 and 2 trials).