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.

Kick-start Towards the Path of Submission Excellence

To decide the best path forward for submissions, the industry considers four (04) major options:

  • A holistic transformation of the submission publishing vertical by changing the entire way it functions regarding process flow and responsibilities
  • A cross-functional and asset-led approach by reimaging how specific assets can be transformed instead of the entire portfolio
  • A functional view of Regulatory aspects by transforming what falls under the domain of the Regulatory Affairs department
  • Investing in specific capabilities that automate the functionality of the submissions and publishing requirements

Reimagining the Submission Process with an Automation Tool

With an automation tool, six (06) key areas can be addressed during the submission process, such as:

  • Presenting a high-quality, user-friendly dossier for Health Authorities to review
  • Streamlining the dossier to simplify the presentation of key messages
  • Optimizing submission processes by reducing errors
  • Enhancing capabilities by upskilling their current submission teams
  • Taking advantage of technology and automation to accelerate submissions
  • Treating Regulatory Agencies as thought partners and working collaboratively

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


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