United BioSource or UBC has expanded its Regulatory Affairs group led by Mark Ammann, and LaVonne Lang.
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The Regulatory Affairs group will be headed by Mark Ammann, a 17-year veteran of the pharmaceutical industry, who most recently held the position of global head of Regulatory Affairs at Pfizer. LaVonne Lang will join Ammann in a leadership role, serving as senior director, Regulatory Affairs.
The group will conduct cradle-to-grave global strategic planning, manage submission and liaison activities with health authorities and handle medical writing of regulatory documents. As part of its mandate, they will offer services to both emerging and established life science companies. Based in Ann Arbor, Michigan, the group will provide a full range of services to pharmaceutical and biotechnology clients, including creating and implementing development plans to fulfill regulatory requirements for initial approval of new medicines and providing life-cycle management for marketed products.
Ethan Leder, CEO and founder of UBC, said: “We are thrilled to welcome Ammann and Lang to the UBC team. They give us world-class experience and expertise in navigating through the drug development process with the FDA. This capability complements our specialized regulatory knowledge in areas like health outcomes and post-approval research to provide clients unique regulatory insight in both the pre- and post-approval environment.”
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