Our Team
Benjamin H. Wimmer
Regulatory Operations & Regulatory Affairs Leader
Benjamin Wimmer joined Biologics Consulting in November 2009 and leads the Regulatory Operations: Publishing/Electronic Submissions team.
Prior to joining Biologics Consulting, Mr. Wimmer worked for the Electronic Publishing team at Pharmaceutical Product Development (PPD), a global contract research organization, and as an Editor’s Assistant for the Journal of Geophysical Research at the American Geophysical Union.
His expertise lies in US-Regional eCTD publishing, validation, and submission of electronic applications (Pre-INDs, INDs, BLAs, NDAs, DMFs, ANDAs) and lifecycle maintenance to the FDA via the Electronic Submissions Gateway. He also has experience in eCTD and NeeS regulatory submissions to Health Canada and the EU.
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