Freyr SUBMIT PRO

Regulatory submissions and publishing tasks have traditionally been laborious involving hours of manual efforts for formatting documents, generating agency-compliant PDFs, doing quality checks, assembling documents for submissions, etc. With the demanding timelines, life science companies always rush for timely submissions. Across the globe, Regulatory bodies are gearing up to adopt recent developments like eCTD v4.0 for dossier submissions, amendments, and other reports.

A multitude of challenges are faced by the Regulatory departments by the move from paper-based to eCTD submissions that continues around the world. Most of the life science companies are struggling hard to keep up with the USFDA standard in using eCTD format and meet the specified deadline. The compulsion of the eCTD format in the US and Canada has enhanced the submission procedure and made it easier by bridging the gap between the time and market which in turn is helping in minimizing expenses on electronic submissions to the pharmaceutical industries.

Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates. The updates focus on addressing a few key constraints that both Agencies and sponsors have discovered over the last two (02) decades.

Pharmaceutical professionals in the Regulatory space face complicated, rigorous, and ever-evolving requirements for the Regulatory approval of products in any market. But as technology advances, our ability to obtain data from other sources also changes. The amount of data in the Life Sciences industry is rising exponentially. The rise of the required information within Regulatory submissions occurs due to the fact that patients can have safer and more effective treatments coming into the market.

eCTD has turned into a standard norm for industry-wide submissions in a majority of regions across the globe. It provided a single standard for the electronic transmission of submissions data and enabled the industry to communicate and exchange information with Health Authorities harmoniously.

For years, Regulatory publishing was done by manual tasks. Publishers used to work for hours formatting documents, generating Agency-compliant PDFs, performing quality checks, compiling documents for submissions, and troubleshooting issues related to submissions.

Moreover, pharmaceutical companies are under immense pressure to submit error-free documents within stringent timelines. The inability to meet the timelines delay the product launch.

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.

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. 

Drug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material. The entire process involves near-constant correspondence between Regulatory affairs departments and the global Health Authorities (HAs).