Electronic Publishing & Submission Management
AARIYA with an extensive eCTD track record has the expertise necessary to successfully manage your electronic submissions in an efficient and cost-effective manner
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Electronic Publishing & Submission Management
As more and more global Heath Authorities are now asking for submissions in the electronic format, the need of the hour is to deploy robust publishing tools to manage region-specific formats.
AARIYA provides dossier publishing & submission services worldwide of utmost quality, supporting both eCTD and Non-eCTD electronic Submission (NeeS) formats. All submissions are compiled as per the Agency specific format using the updated DTD versions. Our experts have diligently curated a double vetting process for the Technical Quality Review of documents which is powered by both our expertise and robust software validators that guarantees an error-free process for your submission.
All submission services are supported by our experienced regulatory publishing team, whose deep knowledge of local and regional guidelines can help streamline your end-to-end submission management process, through:
- Document level publishing by hyperlinking, bookmarking, formatting and converting files to the necessary standards.
- eCTD population and publishing
- Checklist-based validation of documents (which includes verification and correction) as per the specifications laid down in the Agency’s Validation Criteria
- Document and Submission levels Quality Check (QC)
- Legacy paper management and conversion to NeeS to eCTD
- Conversion of DMFs to eCTD
- eCTD lifecycle management for continued support to all future sequences of your application
- Electronic Submission Gateway (ESG) services for securely transmitting submissions to the Agency using authorized submission portal
Apart from deploying experienced Regulatory personnel, AARIYA uses one of the world’s leading publishing software, eCTD Office™, for the creation, validation and publishing of regulatory documentation for electronic submissions of your products – Drugs, Biologics, and Medical Devices.