10 Small Submissions
No more than 10 Documents per submission
Submission excellence can bring benefits to organizations and enhance the ability to launch products more quickly. It cuts short the delay in the process by simplifying and streamlining the organization’s ways of working. Having all the multifunctional submission teams delivering a shared global strategy in addition to collaborating with the Regulators helps to improve the quality of submissions, thereby getting products faster to the market.
In order to avoid the challenges that hamper the process of drug development and approval, it is important to ensure timely review and feedback of submissions to speed up these processes. Also, it is important to set up better-coordinated submission teams to help meet expectations on time and avoid the last-minute rush. By focusing on specific areas of the submission process, submission excellence can be attained.
To decide the best path forward for submissions, the industry considers four (04) major options:
With an automation tool, six (06) key areas can be addressed during the submission process, such as:
By following the approach outlined above, some organizations have been able to reduce their timelines radically. Freyr Digital offers one such automation tool – Freyr SUBMIT PRO that enhances submission excellence. Evaluate Freyr SUBMIT PRO for free