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. We continuously review the marketing authorization and constantly adapt it to current legal requirements. Our high quality standards regarding the authorization dossier give you peace of mind.
Before each submission, the data required for the marketing authorization are defined in a direct discussion with you. Already existing data is subjected to a scientific review and evaluated for you. We develop the optimal and efficient regulatory strategy and align it with your needs. We assess existing dossiers quickly (due diligence) and present you with the resulting options. We prepare the necessary 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.