The pharmaceutical industry is subject to a complex body of laws and guidelines which demand qualified handling of large inventories of data and documents. FDA Rule 21 CFR Part 11, the GxP Guidelines and new regulatory formats such as CTD/eCTD are intertwining and their implementation forms are a challenge for pharmaceutical companies.

To fulfill official requirements, the COI-PharmaSuite module offers you far-reaching support. Innovative and process-oriented standard solutions for electronic regulatory affairs and GxP-compliant documentation was and is being developed in cooperation with our customers and competent partners from the pharmaceutical industry.

Complete solutions are available on the basis of a completely integrated Records Management solution and Information Lifecycle Management solution, building on high-performance technology. Pharmaceutical companies profit from the integrated support of Product Lifecycle Management and the related speeding up of the entire market authorization. In this way, the efficiency of the company can be increased and a reduction of time-to-market can be achieved.