PharmaLex GmbH

Dr. Thomas Schöpke

Dr. Thomas

has been working for PharmaLex GmbH for more than 10 years as Principal Cosultant Regulatory CMC and Qualified Person §15 AMG. His work covers regulatory aspects such as the preparation of registration dossiers including environmental risk assessments, gap and due diligence analyses as well as GMP topics such as SOP preparation and GMP, GDP and GACP audits. He has special experience in the sector of handling deficiency letters in marketing authorization procedures. As a qualified pharmacist, he also lectures continuously as a private lecturer at the University of Greifswald on the lecture cycle "Fundamentals of Systematics and Taxonomy".

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