Regulatory Maintenance   Extensions strategy Discuss with us your submission strategy to find out what suits best for line extensions or other amendments to your approved product. Find out the advantages and pitfalls of the respective European submission procedures. Decide on the basis of our advice whether the electronic compilation can be beneficial for your submission. <- back Project management Rely on our team to help you managing all the tasks involved in the complex registration process. A project manager assigned to your project will follow-up with internal and external experts to include their expertise into your project. The project manager acts as your primary contact for all upcoming issues as the registration process proceeds. We will liaise with the project manager assigned by the regulatory agency to ensure smooth progress of your registration. <- back Compilation management You decide on the format of your submission, we take care of the all the rest. We compile your scientific results into a regulatory dossier that is fully in accordance with all current requirements. Discuss with our experts to find out how an electronic submission could improve the review process at the authorities. We compile your electronic dossier according to the current regulatory standards. We are able to prepare and submit guidance conforming eCTDs. If your target regulatory authority has special requirements, we can easily include this in the compilation process. We convert your existing dossier to either the new CTD or to a real eCTD. If your target authority requires paper dossiers to be submitted, we take care of all the copy and paper handling work. <- back