Regulatory Affairs
All medicines in the Netherlands must be granted a marketing authorisation by the Dutch Medicines Evaluation Board (CBG-MEB) before going to market. Our Regulatory Affairs department coordinates the lengthy process of applying for marketing authorisations.
To obtain marketing authorisation, the team compiles technical dossiers describing all aspects of a medicine: from production to packaging, side effects and use.
These regulatory dossiers are meticulously crafted to provide the CBG with irrefutable evidence of our medicines’ quality, safety and efficacy. This crucial aspect of our work requires accuracy, the ability to solve complex problems and a deep understanding of our products and the regulatory landscape.
