The Life Science industry is confronted with continuously rising number of official requirements concerning formalities. Moreover, the market demands still shorter response times under preservation of high quality standards. The European Union (EU) and the responsible authority FDA in the USA have passed further guidelines and laws. Compliance with these is checked more strongly now and non-compliance is penalized by even harsher measures.

COI-PharmaSuite is a standard software solution based on COI-BusinessFlow, which COI has especially developed for the pharmaceutical/life science industry for the areas of drug admittance and GxP documentation. Ongoing development based on the legal requirements guarantee the dependability of the data and the market authorization for drugs.

COI-PharmaSuite –RegulatoryAffairs

Standard software for market authorization for drugs and dossier administration:
Based on COI-BusinessFlow the module "Regulatory Affairs" this supports the entire core process of drug admittance in accordance with the official requirements. Beginning with the production of the first documents relevant for registration these can be already recorded in the system, from where they are administered and made available to the registration department for the dossier production. This forms the base for an companywide knowledge management. Predefined document sets and structure envelopes (e.g. in the CTD format) simplify dossier construction. Clearance and control mechanisms with corresponding access authorizations provide higher quality and better security.

COI-PharmaSuite –eCTD Export

The eCTD Export represents an integrated component of the COI-PharmaSuite which enables electronic submission in accordance with the official requirements. Drug dossiers can be exported to the file system in the eCTD format. The eCTD Export follows the specifications laid down in "ICH eCTD Specification V 3.2, February 2004".

A central XML file is produced which corresponds to the DTD (Document Type Definition) of the eCTD and contains the navigation and meta information of the exported documents. Furthermore a stylesheet component which manages an easily readable HTML representation of the central XML document is included. The HTML display allows, among other things, a comfortable navigation to the exported documents.

COI-PharmaSuite –GxP-Documentation

By use of an electronic document management system (eDMS) the quality of the documentation in the GxP environment can be improved and the associated costs can be reduced with a lasting effect. The system allows a more efficient production, handling and archiving of extensive document volumes. Integrated in the eDMS complete are a complete lifecycles and workflows for admittance documents, SOPs, quality and management manuals as well as the officially required production documentation.

The COI-PharmaSuite's GxP Documentation supports you in the construction, structuring and the productoin of the demanded documentation. It is a tool to keep relevant documents up-to-date and to allow employees to access them at any time and from anywhere.

COI-PharmaSuite –AMG-EV-Dossier Module

The COI-PharmaSuite supports the submission procedure with its module AMG EV Dossier for sections of drug applications (admittance, post-admittance, prolongation, change notification) for the 'Bundesinstitut für Arzneimittel und Medizinprodukte' (BfArM), German Federal Institute for Drugs and Medical Devices. The information previously produced only in written form and transmitted information/data for the drug admittance must be submitted by the applicants via electronic means since February 2004. In accordance with the new regulation AMG-EV submission can only be carried out by e-mail, optionally PGP-encoded. Disks or CDs are no longer accepted by the federal authority. The AMG eV Dossier module determines the files required for submission directly from [e]CTD dossier and labels them according to the file naming convention.