Regulatory submission software - key considerations to choose

As many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key measures to submit documents in the electronic format to remain compliant. 

The eCTD publishing and submission is a cumbersome process that requires the cooperation of multiple individuals from various departments within the organization. Also, it is paramount that Standard Operating Procedures (SOPs) and clear expectations are established to streamline the process, which requires ample time and proper planning.

The quick path to simplify such Regulatory processes is to choose a Regulatory submission software with an integrated document management system and dossier publishing solution. The software streamlines the submissions process with the utmost possible data accuracy. Selecting the best software in a huge pool of resources can be challenging. Here are a few basic considerations one must look into while choosing a Regulatory submission software. The software must:

  • be a lightweight, easy-to-use web-based application
  • be able to create, track, validate, view, publish and manage the entire document life cycle, including pre-clinical/clinical research data
  • support region-specific submission formats under strict eCTD guidelines and compliance timelines
  • have an inbuilt eCTD validator to check compliance
  • have an inbuilt viewer to review the region-specific submission lifecycle
  • have end-to-end tracking traceability
  • have Health Authority query management system
  • provide alerts for submission due dates and Health Authority activities to mitigate the risks of missing deadlines

Apart from the features mentioned above, the software must have a seamless workflow from creation to publishing.

In a nutshell, it is crucial for manufacturers in the Life Sciences Industry to streamline the submission process with the best Regulatory publishing software to manage the multitude of Regulatory submission requirements. Here is an opportunity to go through a proven software – Freyr SUBMIT PRO. Request a demo.