For years the pharmaceuticals industry has been calling for the use of electronic systems in the field of drug certification. Submission of a new drug currently takes several years and is very complex and time-consuming. Delays in regulatory affairs may have consequences of turnover losses running to tens of millions. Every reduction of the time-to-market is critical here. The certification decision determines profit or loss and is frequently refused due to form errors. Every certification submission consists of many documents which have to be compiled in strictly defined formats. With today's still paper-based regulatory affairs process, there are mountains of files and volumes of paper to manage and also comply with all statutory regulations and guidelines.

COI-PharmaSuite represents the solution for optimization of this important core process. Documents produced at an early stage are electronically compiled and automatically administrated within the framework of the subsequent certification structure. The entire certification process is currently subject to changes due to implementation of the Common Technical Document (CTD). COI-PharmaSuite supports these changes by means of complete mapping of the CTD format.

In addition, the solution today offers you support of the Electronic Common Technical Document (eCTD) format. An integrated system with integrated eCTD format is a secure investment for your future.