Smarter the eCTD publishing software, smoother will be the eCTD submissions process. The Life Sciences and Medical Device companies are looking for a robust and effective submission publishing software to gain fast-track approval from regulatory agencies for marketing new drugs, biologics and devices. The documentation Lifecycle covers a complete clinical and preclinical research data accumulated over the years. And the submission requirements vary depending on the specific regulations of each country; USA, European Union, Canada, GCC, Saudi Arabia, Oman, South Africa, Switzerland, Australia, New Zealand, Bosnia & Herzegovina, and Thailand. As companies move towards fulfilling their submission obligations, either DMF or SPL or baseline submissions, under strict compliance timelines, they face increasing complexities to efficiently manage multiple documents and different formats across the entire submission process.
Some of the major challenges faced by the companies 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
- 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 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 formats / templates
- Our 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 software with advanced reporting, audit trail and admin features
- Seamless integration with prominent DMS
Regulatory Submission and Publishing CoE
As an effective and robust submission-friendly eCTD software on a secure cloud environment backed by a well-versed regulatory team keeping track of ever changing regulatory guidelines, Freyr offers companies the best of both worlds – on-demand eCTD software as well as a Centre of Excellence that offers best in class, cost-effective and custom eCTD outsourcing service models built around clients’ unique and demanding eCTD software requirements.
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