At Eurofins, we have technical experts in all disciplines who constantly keep their knowledge up to date on all the evolving technical data requirements and guidance documents.
Maintaining and developing this expertise is our priority, enabling us to identify and address specific technical issues that may arise. We offer strategic advice to clients on the best way to proceed by identifying data requirements best suited to the clients regulatory objectives through support to full life-cycle-management.
We are confident in our knowledge of recent developments and changes to the current regulations; this allows us to update Eurofins Study Directors on new developments directly in-house.
The experts at Eurofins Regulatory AG are well placed to provide up to date advice on new guidance initiatives, new study designs and new tactical approaches which can be implemented quickly and efficiently.
We are mindful of all developments within these areas and are able to advise on implications of evolving data requirements. We have expertise in identifying any additional studies and risk assessments required to upgrade existing dossiers to meet current regulatory requirements. Regulatory support does not necessarily stop at the dossier submission. It can continue with a life-cycle-management of the active and/or formulation...
We are ready to offer the full program of support
Eurofins Regulatory AG can liaise with regulators to help answer any questions that may arise during the evaluation of your dossier. The team are closely linked to the major markets and can ensure all regulatory requirements are met with local and national requirements taken into consideration.
There is no doubt that the current regulatory environment and constant evolution of legislation will remain a constant challenge.