Pre-approval phase   Regulatory strategy Discuss with us your regulatory strategy to find out what suits best for your product. Find out the advantages and pitfalls of the respective European submission procedures (national, decentralized, mutual recognition, or centralized). Keep in mind that time spent in the strategic planning pays back tenfold in the development and registration process. We will line out implications of the various regulatory procedures as both content and format of your documents will be impacted by this choice. Decide on the basis of our advice whether the electronic compilation would be of benefit for your submission. Whether you want to acquire a license from a partner or intend to submit an existing product to new countries, we evaluate existing regulatory dossiers, point out potential weaknesses and revise the documentation to make it comply with current regulatory standards. <- back Development coordination We support your team from early on to ensure speedy development. Lionpharm will either give direct input or suggest partners for specific tasks. We'll liaise with scientific contractors and coordinate their input to produce the best value for your development. <- back Pharmacology and toxicology We can design the complete pre-clinical program for your product as it is being specified by the various regulations. We evaluate your pharmacological and toxicological studies. For existing drug substances, we research published evidence in various databases as a basic for a bibliographic documentation. We compile the scientific results into a regulatory dossier in accordance with all current requirements. We summarize the key points of your product's dossier in the pre-clinical overview and summaries or any other format of an expert report. <- back Clinical efficacy and safety We can consult you in designing a clinical program or single studies for your product in accordance with current GCP requirements. We evaluate your clinical studies. For existing drug substances, we research published evidence in various databases as a basic for a bibliographic documentation. We analyze all published evidence including your own clinical studies by various statistical means. Depending on the data quality, we may decide to present the result of the evaluation either in form of a structured review or as a meta-analysis. We compile the scientific results into a regulatory dossier in accordance with all current requirements. We summarize the key points of your product's dossier in the clinical overview and summaries or any other format of an expert report. <- back Pharmaceutical quality We are ready to develop a pharmaceutical formulation in order to transform your ideas into real-life drug products. We evaluate your existing manufacturing documentation as well as related data. If you need help with the evaluation of a new manufacturing site, e.g. set-up of a new site or inclusion of a contract manufacturer, we can check adherence to cGMP or suggest implementation of appropriate measures. If required, we may develop an analytical method to determine e.g. your drug substance in a newly formulated drug product. We can perform the analytical method validation for non-pharmacopoeial methods that are included in your documentation for pharmaceutical quality. If you need stability information in accordance with current ICH guidelines, we could either perform a complete stability program or generate data to bridge from new stability lots to your existing batch data. We also provide help in the design for stability studies that shall be run in your own laboratories. We compile the scientific results into a regulatory dossier in accordance with all current requirements. We summarize the key points of your product's dossier in a quality overall summary or any other format of an expert report. <- back Medical writing We review or prepare a Summary of Product Characteristics or a patient information leaflet based on the dossier you provide to us. We prepare expert reports, i.e. common technical document overviews and summaries for your submission. <- back Regulatory operations Regulatory data need highly specific ways of presentation. Rely on our experience gained from lot of different products and let us optimize your documentation with regard to the review by your target authorities. We are ready to handle all file formats, therefore we can easily present the information in a way that suits the reviewer best. Digitalization of non-editable files and conversion into an editable format are no problem for us. Learn about how hyperlinking your dossier can improve both internal quality control and external review. <- 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. <- back