Principal Consultant
Granzer Regulatory Consulting & Services GmbH, Germany
Matthias Dormeyer is the Managing Director of MDC RegAffairs GmbH, a service provider in the fields of regulatory affairs.
In his work he has focused on designation, development and authorization of orphan drugs in the EU and US. Another area of expertise are paediatric drugs (including drafting and submission of Paediatric Investigations Plans (PIPs) and Request for Waiver) and management of marketing authorization applications under the centralized procedure. His expertise comprises small molecules, protein drugs as well as advance therapies for the treatment of a wide variety of diseases including for example cancer, autoimmune diseases, ophthalmological conditions, or infectious diseases.
After finishing his doctorate he worked at Knoll AG (now Abbott) in the field of early ADME. In January 2000 he joined 4SC AG, a biotech in Martinsried/Munich. His initial assignment was to set up to biological department and screening facilities. He then moved into project management and was among other responsible for the transition of projects from research to development and non-clinical and early clinical development of 4SC’s pipeline projects. He started his career as independent consultant and service provider after he left 4SC in 2006. In 2009 and he founded MDC RegAffairs GmbH.
Matthias Dormeyer is a chemist by training and holds a PhD in biochemistry as well as a Master in Drug Regulatory Affairs (MDRA).
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Drug Development in EU: Regulatory Standards, Support and New Approaches
Tuesday, October 3, 2023
8:30 AM – 4:00 PM EDT