eCTD Now Inc.

Based in Montreal, Canada, eCTD Now is a company fully dedicated to support the pharmaceutical industry in all aspects related to the electronic regulatory submissions. Our services include, but not limited to, the following: • Consulting: - Select eCTD software and/or implement a publishing capability in your organization including processes and resource management - Help you making the decision on outsourcing vs housing your eCTD publishing activities - Improve the quality of your publishing processes and documentation quality and workflow to meet the electronic regulatory requirements • Training: - End to end training on eCTD submission format to Health Canada (HC), US Food and Drug Administration (US FDA), Health Medicines Agency (HMA), European Medicines Agency (EMA) and Gulf Cooperation Council (GCC) including Saudi Food and Drug Authority (SFDA) - Training on setting up of gateway accounts and filing of eCTD submissions via the different gateways (ESG, CESG, CESP, WebClient) - Training on strategies and tips for a high quality eCTD output and regulatory document and dossier lifecycle management • Publishing: - Publishing of your regulatory dossiers and transactions in eCTD format according to the highest standards ensuring successful electronic validation and processing of your submissions by the health authorities. We publish in eCTD format for HC, USFDA, HMA, EMA and GCC - Filing of eCTD outputs via the gateway to Health Authorities - High quality lifecycle management of regulatory documents and submissions Your success in electronic regulatory submissions is our goal! We are committed to delivering the highest quality first time.