10 Small Submissions
No more than 10 Documents per submission
On-time Regulatory submission is the key to achieve quick time-to-market. But, with a lack of planning, the industry could face a lot of complications which may result in rejected submissions, delayed market-entry, increased costs due to extended timelines. Hence, it is necessary to develop a concrete submission plan and identify where technology can help improve Regulatory submissions.
Health Authorities are now going the eCTD way! Many countries, such as the US, Europe, Canada, South Africa, Australia, Thailand and Japan, have already chosen eCTD as a standard format for submissions because of the various advantages like:
Though the format seems to be advantageous, eCTD Regulatory submissions are not simple. The process can be time-consuming and highly prone to errors, if not executed in the right manner. By using an eCTD tool, it is easy to significantly increase the quality and reduce the preparation time. Here are the ideal features to consider while choosing Regulatory publishing and submissions software:
To conclude, as global Health Authorities are making eCTD submissions mandatory and trying to harmonize the global Regulatory requirements for streamlined submissions, companies must act wise and deploy a software solution that indeed shall suit all the global submission requirements. Evaluate Freyr SUBMIT PRO for all your publishing and submission requirements. Request a demo.
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