MDC RegAffairs GmbH

Events:

  • „Projektmanagement in pharmazeutischer Forschung & Entwicklung“
    Köln, 17./18. März 2016
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  • Der CMC-Manager in Regulatory Affairs Köln, 2.12.2015 - 4.12.2015
    Read More
about

About MDC RegAffairs

MDC RegAffairs was founded by Dr. Matthias Dormeyer in 2009. He is a chemist by training and holds a Ph.D. in biochemistry and a master degree in regulatory affairs (MDRA).

Matthias works in the pharmaceutical industry for more than 15 years. In his work he has focused on designation, development and authorisation of orphan drugs in the EU and US. Another area of expertise is paediatric drugs (including drafting and submission of Paediatric Investigations Plans and Request for Waiver) and management of marketing authorisation applications under
the centralised procedure. His expertise comprises small molecules, protein drugs as well as advance therapy medicinal products (ATMP) for the treatment of a wide variety of diseases including for example cancer, autoimmune disorders, ophthalmological conditions as well as dermatological, metabolic and infectious diseases.