contractpharmaApril 01, 2020
Tag: Q BioMed , Geoff Fatzinger , Strontium89
Q BioMed Inc. has appointed Geoff Fatzinger as Global Head of Regulatory Affairs, responsible for providing strategic regulatory oversight to Q BioMed for product development and commercialization. He will focus on developing the global regulatory approval strategy for the commercialization of Q BioMed's lead product, the FDA approved, non-opioid Strontium89 (Strontium Chloride Sr-89 Injection, USP). He will also contribute strategic regulatory insight and guidance to the company's portfolio of earlier stage assets.
Geoff has more than 20 years of regulatory expertise, having been directly involved in all phases of product development with regulatory and business accomplishments covering the U.S., Europe, Middle East and Asia Pacific. His specialties include global product regulatory strategy development; market assessments; agency interactions; Health Economics Outcomes Research (HEOR) and Regulatory Economics; drug and device development; clinical trials, and approvals.
"We are very happy to have Geoff join the team at Q BioMed. His deep global regulatory expertise and strategic leadership is critical as we reach some important milestones, including our effort to globally commercialize Strontium89," said Q BioMed CEO Denis Corin. "We look forward to his contributions and are pleased with the strength we've continued to build in our leadership team."
Q BioMed received FDA approval to manufacture and distribute Strontium89 in November, 2019. The Company completed its initial commercial production run and shipment in February and has begun distribution in the US, with distribution to EU and rest of the world expected later in the year.
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