Product Information

MasterControl Registrations™ for eCTD

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Data Sheet 1 Data Sheet REGULATORY MANAGER CTD DOCUMENTS TASK STATUS SUBMISSION PL ANNING AMENDMENTS CTD CHECKLIST SUPPLEMENTS JAPAN UNITED STATES AUSTRALIA REST OF WORLD EUROPEAN UNION MasterControl Registrations™ for eCTD Registering new products in different countries is a time-consuming and nerve- wracking process. While the information required is essentially the same for various registrations as many countries have adopted the Electronic Common Technical Document (eCTD) standard, the preparation, presentation, and the depth of information submitted vary greatly depending on regional requirements. For pharmaceutical and biotech companies, product registration comes on the heels of a grueling regulatory approval process of a new marketing application (i.e., MAA, NDA, BLA, IND). Drug development typically takes 10 to 15 years, so time is of essence in product registration in order for a sponsor to start generating return on investment. What is MasterControl Registrations for eCTD? MasterControl Registrations is a holistic solution for product registration and eCTD submission management that will automate your manual or hybrid processes. It will streamline control of documents and timelines, as well as tracking of various requirements for every geographic location. It will create transparency for effective monitoring of bottlenecks within your organization and those involving regulators.

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