Effortlessly view submissions with full lifecycle support and workflows
Save time identifying dossiers of interest, by easily searching on metadata
Supports global regulatory standards and legacy versions of eCTD
Regulatory submissions involve different stakeholders, multiple types of content, and a variety of systems. Viewing and reviewing the different aspects of each submission is a complicated, yet critical undertaking without a single source of truth.
eSUBmanager is a browser-based reviewing software that offers a centralized overview of regulatory submissions with easy access from anywhere.
All regulatory submissions start their life as a number of discreet documents and fragmented metadata. These documents are created from multiple systems by different authors focusing on unique content before being compiled into a submission. Organizations who want to view and review the important files within a regulatory submission often find this challenging. After the compilation process, few tools are able to access and view individual files within submission compilations for review purposes.
EXTEDO eSUBmanager improves the collaborative viewing, reviewing and tracking process surrounding submission content and metadata in readiness for transmission to the regulatory authorities. As a centralized solution for the viewing and reviewing of submissions, users can view multiple types of documents, files and folders before publishing in eCTDmanager.
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“EXTEDO is a great example of a company that really understands the requirements of the market.”
Director Business Development, Technical Operations and international Business at Genericon
Your plan to effortless compliance
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Manage your regulatory submissions centralized from anywhere
Improve the collaborative viewing, reviewing and tracking process surrounding submission content and metadata in readiness for transmission to the regulatory authorities
Some of our Customers
Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.