Smarter the eCTD publishing software, smoother will be the eCTD submissions process. But to ensure the smoother submissions, life sciences organizations must consider the wide variety of documentation they need to manage. The entire documentation Lifecycle covers a complete clinical and preclinical research data accumulated over the years. In addition, region-specific submission requirements (across the USA, the European Union, Canada, GCC, Saudi Arabia, Oman, South Africa, Switzerland, Australia, New Zealand, Bosnia & Herzegovina, and Thailand) vary depending on the respective Health authority (HA) regulations and, thus the submission templates and formats. Likewise, as organizations move towards fulfilling their submission obligations, either DMF or baseline submissions, under strict compliance timelines, they face increasing complexities to efficiently manage different eCTD templates / formats across the entire submission lifecycle.
Some of the major challenges faced by organizations include:
- Need for a robust regulatory publishing software to streamline and effectively manage the entire Lifecycle, and to root out all errors during the submissions compilation and validation
- Ineffective submission solutions due to partial integration with commonly available DMS
- Unending performance issues due to complex architecture & unnecessary features of eCTD software
- Unfriendly and rigid eCTD submission software structure with limited customizable product features
- Unavailability of end-to-end eCTD Software vendors
In such scenarios, life sciences organizations look for a robust and effective submission publishing software / eCTD Regulatory software to gain approvals from HAs on fast-track basis for marketing new drugs, biologics, and devices. Freyr as an end-to-end eCTD Regulatory software provider assists organizations with Freyr SUBMIT to effectively handle all the Regulatory submissions requirements, i.e. handling end-to-end document lifecycle and region-specific eCTD templates / formats.
Freyr SUBMIT Capabilities
Freyr SUBMIT Features
- A lightweight and faster application built on a robust architecture with a simple, user-friendly interface
- A ready-to-use, flexible and cost-effective eCTD Regulatory software offered either as a cloud hosted or on-premise deployable model
- Easily processes US, EU and GCC, Australia Thailand eCTD submissions with automated system-defined eCTD templates / formats
- Our web based eCTD software supports emerging markets’ submission requirements
- Enables automated template library updates (for all formats / templates) with systematic and customized notifications
- Advanced features to efficiently manage the entire eCTD Lifecycle
- Completely customizable eCTD Regulatory software with advanced reporting, audit trail, and admin features
- Our cloud-based eCTD solution enables seamless integration with prominent DMS
Regulatory Publishing and Submissions CoE
As an effective and robust submission-friendly cloud-based eCTD solution backed by a well-versed regulatory team keeping track of ever-changing regulatory guidelines, Freyr offers the best of both worlds – on-demand eCTD Regulatory software, Freyr SUBMIT, as well as a Centre of Excellence that offers best in class, cost-effective and custom eCTD supporting service models built around clients’ unique and demanding eCTD Regulatory software requirements.
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