BETHESDA, Md., Feb. 25 /PRNewswire/ -- United BioSource Corporation (UBC) today announced the expansion of its Regulatory Affairs group led by distinguished experts Mark Ammann, Pharm.D. and LaVonne Lang, Dr PH. 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.
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The Regulatory Affairs group will be headed by Dr. Mark Ammann, a 17-year veteran of the pharmaceutical industry, who has worked with products from early development to post-marketing product support in such diverse therapeutic areas as CNS, oncology, dermatology, inflammation, endocrinology and cardiovascular disorders. Dr. Ammann most recently held the position of Global Head of Regulatory Affairs at Pfizer Corporation where he was responsible for several therapeutic areas including central nervous system, inflammation and dermatology.
"We are thrilled to welcome Dr. Ammann and Dr. 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," according to Ethan Leder, UBC CEO and Founder.
"Having led many interactions with the FDA over the past 16 years, I am particularly excited about helping clients navigate through the maze of evolving regulations, offering them counsel about the impact of these changes to their programs," says Dr. Ammann.
Dr. LaVonne Lang will join Ammann in a leadership role, serving as Senior Director, Regulatory Affairs. Dr. Lang has 18 years of experience in pharmaceutical development, with 12 years in positions of increasing responsibility in regulatory strategy at Parke-Davis and Pfizer.
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.
United BioSource Corporation (UBC) is a global pharmaceutical services organization that helps emerging and established life science companies develop and commercialize medical products. UBC specializes in offering new and innovative ways to study drugs and devices by offering expertise in science, strategy and execution.
UBC is headquartered in Bethesda, Maryland, with offices in the United States, Canada, Eastern and Western Europe and South America. For more information, visit www.unitedbiosource.com or call 866-458-1096.
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CONTACT: Tess Drahzal of United BioSource Corporation, +1-240-644-0420,
info@unitedbiosource.com
Web site: http://www.unitedbiosource.com/
