Save time and money
Thanks to our many years of expertise, all processes relating to the marketing authorization are handled for you quickly, efficiently and cost-effectively. Our high quality standards regarding the authorization dossier give you peace of mind.
Before each submission, we define the data required for the marketing authorization in direct exchange with you. We assess existing dossiers quickly (due diligence) and present you with the resulting options. In line with your needs we develop the optimal and efficient regulatory strategy.
We prepare meetings with the authorities (scientific advice, pre-submission) and accompany them throughout the entire process. We carry out project management and communication with contract manufacturers in a target-oriented manner and report on an ongoing basis.