United BioSource Corp. (UBC) has expanded its regulatory affairs group led by Mark Ammann, Pharm.D. and LaVonne Lang, Dr. PH. The group, based in Ann Arbor, MI, will provide a full range of services to pharma and biopharma clients, including creating and implementing development plans to satisfy regulatory requirements for the approval of new drugs and providing life-cycle management for marketed products
   
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 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 Corp., where he was responsible for several therapeutic areas including CNS, 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 chief executive officer and founder.
   
Dr. Lang will serve 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 global strategic planning, manage submission and liaison activities with health authorities and handle medical writing of regulatory documents. They will offer services to both emerging and established life science companies.