Registration Process   Regulatory advice Discuss with us your submission strategy to find out what suits best for your product. Find out the advantages and pitfalls of the respective European submission procedures and make the choice that will allow for short time-to-market for your new product. 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 Dossier evaluation We review your existing regulatory dossiers, point out potential weaknesses and make it comply with current regulatory standards. If you plan the acquisition of a new product, we thoroughly evaluate the documentation to give you a good estimate of its value. If required, we will suggest and implement corrective measures in order to make the dossier comply with current regulations. <- back Documentation service We provide medical writing, regulatory document authoring, and review services on all scales for pharmaceutical quality, pre-clinical as well as clinical documentation. We compile your complete dossier consisting of pharmaceutical quality, preclinical and clinical documentation. By adding hyperlinks to your dossier, we make it transparent and easy to use for internal and external reviewers. <- back Compilation management You decide on the format of your submission, we take care of 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 Electronic submission We are specialized in electronic compilation of dossiers. Discuss with us to find out how the electronic approach could bring benefit to your regulatory processes, your team, and your submission. Find out which format is required for your submission and learn about the special requirements related to electronic submissions. We compile your electronic dossier according to the current regulatory standards. We are able to prepare and submit eCTDs in full accordance with current regulations. If your target regulatory authority has special requirements, we can easily include this in the compilation process. We convert your existing electronic dossier, e.g. from DAMOS or any other format to eCTD. We may also digitalize your paper dossier into standard electronic, editable formats. Moreover we suggest including hyperlinks to improve the navigation for the reviewer as well as for your review staff. <- back Deficiency response coordination Responses to deficiency letters are always time-critical. Therefore, make sure to plan for sufficient resources and carefully set internal timelines. Rely on our team to help you managing all the tasks involved in this complex process. A project manager assigned to your project will follow-up with internal and external experts to include their expertise into your project. He will also ensure strict adherence to the given timelines. 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 Submission service If you want to run a second application for a marketing authorization currently under review, we take over the responsibility for this project. Lionpharm can submit marketing authorization applications at regulatory agencies in its own name. We can represent your company in hearings at the regulatory agencies or for scientific advice meetings. We perform the full scale of regulatory maintenance activities for your approved medicinal products. <- back