DOCmanager Module for Global eSubmission Management
Reducing the effort of managing multi-region product dossiers.
Benefits
Creation and efficient maintenance of many child dossiers based on one parent dossier. Any changes there are automatically inherited by the child dossiers
Reduce errors and increase productivity through advanced automation.
Reduces update times for variations and streamlines the process of managing submissions.
Ease in handling open and restricted information in dossiers (e.g. EU ASMF).
Streamlining global submissions with DOCmanager
EXTEDO’s DOCmanager, an extension to eCTDmanager, helps you address the challenges associated with creating and managing regulatory submissions across multiple regions. Through the use of a parent-child dossier concept DOCmanager enables you to readily generate templates for multiple submissions through simple country level changes whilst keeping common data managed at a product level. You can reuse the content for dossiers based on different submissions scenarios, thus reducing the efforts associated with compiling and maintaining multi-region product dossiers.
Any changes you make to the parent dossier are automatically inherited by the child dossier, thus eliminating the need for revalidation. DOCmanager supports eCTD submissions according to the European MRP and DCP procedures, thus enabling you to update individual submissions or create group updates.In addition, DOCmanager enables you to create inter- and intra-document hyperlinks as well as print publishing templates that are maintained on the parent dossier and can be passed on to child dossiers. This allows you to manage changes at any level by simply inserting a single change and then passing it on to all child dossiers.
By using Document Queries you can search for documents with specific metadata and place these documents automatically into the eCTD structure within eCTDmanager. Used by SMBs and multi-national companies around the globe, DOCmanager is the proven solution for efficiently managing regulatory submissions in multiple regions. It saves time, reduces your costs, and eliminates the errors associated with traditional manual dossier management techniques.
Resources
eCTDmanager product information
eCTDmanager enables you to readily build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF and other submission structures. Now you can get to market faster.
DOCmanager module information
DOCmanager is an extension to eCTDmanager that enables users to re-create dossier templates for different submission requirements with a “parent / child” concept. It significantly reduces the time require to update variations.
Services
Business Process and Regulatory Consulting Services
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.
Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
Technical Consulting
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.
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