Solution for Regulatory Affairs (SubmissionExpert)

In today’s extremely complicated regulatory environment it is no longer possible to meet challenges of tomorrow with yesterday’s tools, and preparing a registration dossier in time and to the satisfaction of the regulatory agency is considered one of the biggest challenges that every day operation of pharmaceutical industry is facing.

The quality of a software solution has already become the comparative advantage on the drugs’ long journey from an idea to the market.

SubmissionExpert is part of INFOTEHNA myPharmaExpert Suite specially designed for the needs of regulatory affairs and features:

• Comprehensive submission lifecycle management
• Built in support for national, centralised, decentralised and mutual recognition procedures
• support of all dossier publishing formats, including NTA 98, CTD, eCTD or other country specific submission formats (CIS region, ASEAN countries, etc.)
• Preconfigured registration dossier templates,
• Assembly and submission publishing in PDF and eCTD format
• CTD (PDF) and eCTD Publishing from the same structure
• Built in all of the technical controls for 21 CFR part 11 compliance
• Automatic upgrade of the dossier when a change is sent to the authority

SubmissionExpert makes sure, that mountains of paper, the brand of every regulatory affairs department for so long, will disappear.

Read more about SubmissionExpert