Freyr SUBMIT PRO

Are you tired of grappling with complex USFDA compliance procedures? Look no further than a robust submission software! Regulatory submission software streamlines your organization's compliance efforts, simplifies the Regulatory process, and ensures that you stay on top of the latest guidelines. With real-time updates and easy-to-use interfaces, submission software takes the guesswork out of compliance and puts you in control. Hence, say goodbye to cumbersome paperwork and hello to a more efficient, effective USFDA compliance strategy with submission software.

Hello, esteemed Regulatory professionals! As a member of the life science industry, you are likely to be familiar with the electronic Common Technical Document (eCTD) submission format that is revolutionizing the Life Sciences Regulatory industry. Its standardized structure is a true game-changer. With this blog, we aim to provide valuable insights into the best practices for eCTD submissions. So, let's get ready to become eCTD submission experts together!

Electronic submissions have taken the life science industry's Regulatory space by storm. Majority of the Regulatory submissions are now made using the eCTD format globally. The benefits of eCTD are undeniable - faster, more efficient, and standardized. But transitioning from non-eCTD electronic Submission (NeeS) to eCTD isn't always a cakewalk. In this blog, we'll dive into the benefits of eCTD, the challenges of transitioning, and some strategies to successfully transition to the electronic world of submissions.

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.

China’s pharmaceutical industry has seen substantial growth since its entry into the World Trade Organization (WTO). As of 2021, China holds a 12% share of the global pharmaceutical market, making it the second largest contributor. According to Xinhua News Agency, the Chinese pharmaceuticals market generated 708.75 billion yuan in 2021, while the Chinese domestic medicinal companies amassed 502 billion USD in profit.

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.