ectd software services
- Freyr Global Regulatory Solutions
- Sep 19, 2017
- 1 min read
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.
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