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.
Approaches to include drug substance quality information in a drug product application (June 2022)
Author: Esther Meeuwissen
How to select a cell line to produce a biosimilar (June 2021)
Contact: Valentyna Starodub
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