Mastering the current standards and guidelines in order to obtain marketing authorization for drugs is just one of the challenges facing pharmaceutical companies today. Adherence to official guidelines, or "compliance", has long since been obligatory for authorization departments. It is much more important to reduce the time-to-market for drugs in order to ensure market exploitation as long as possible until expiration of the patent. The Regulatory Affairs department, which acts as the central interface between the company and the regulatory authority, plays a decisive factor in this process. The document management solution Regulatory Memory enables efficient and convenient re-utilization of the dossier content and, in addition to a higher degree of transparency, also results in a significant reduction of the submission process.

fme Regulatory Memory is a document management solution for the electronic compilation, submission and maintenance of dossiers. Regulatory Memory fulfils all of the current regulatory standards and guidelines. In addition to pure dossier publishing the solution also offers important functions for the integration of other document management applications, such as tracking functions for ensuring the traceability of document delivery. This ensures a significant reduction of the submission process and also paves the way for simplified, error-free communication with departments supplying the documents.

BENEFIT

• Significant time reductions and safeguarding of the quality are ensured by submission of the dossiers in various formats (eCTD, CTD, NEES) and the utilization of a single master dossier for various countries and authorities
• Reduced costs for dossier maintenance thanks to efficient and convenient re-utilization of dossier content
• Reduction of process times is ensured, for example, by the simplified exchange of documents with supplying departments