MDC RegAffairs GmbH


  • „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
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At MDC RegAffairs we are particularly focused on the development and authorisation of drugs for children and orphan drugs as well as European authorisation procedures.

Our services comprise preparation of regulatory documents, management of regulatory procedures at national agencies and the European Medicines Agencies (EMA), and organisation of agency meetings. In addition, we offer In-House seminars on regulatory topics and project management in R&D.

Our core expertise is:

Orphan Drugs

Paediatric regulation

European Authorisation Procedures

Drug development

In-House Training