White papers
Our white papers show you topics we work on. The white papers contain a summary of the current guidance and our general advise on the topic. For advise specific to your company and product, feel welcome to Contact us.
How to select a cell line to produce a biosimilar (June 2021)
Author: Anna Klaassen-Karataeva
Combination products in the EU MDR (May 2021)
Author: Patrick Vronen
News on the Postponement of the EU Medical Device Regulation, Corrigenda and MDCG guidance (June 2020)
Contact: Valentyna Starodub
EU MDR impact on importers and distributors (March 2020)
Contact: Valentyna Starodub
Radiopharmaceuticals – How to Register in EU? (October 2019)
Contact: Valentyna Starodub
Is your Active Pharmaceutical Ingredient quality control strategy up to standard? (July 2019)
Contact: Valentyna Starodub
What is new under the EU MDR for software manufacturers? (December 2018)
Contact: Valentyna Starodub