The Complete Guide to Regulatory Submission Software for Life Sciences

Introduction to Regulatory Submission Software

In today’s heavily regulated life sciences landscape, the role of regulatory submission software has become pivotal for companies seeking to bring products to market efficiently and maintain global compliance. Regulatory submission software is a digital solution streamlining the submission process, from document preparation to final submission tracking. These systems automate essential tasks, ensuring that life sciences companies remain compliant, avoid costly delays, and maintain accurate records based on various HA guidelines.

Unlocking Data Privacy and Security: A Game-Changer in Regulatory Submissions


In the dynamic landscape of pharmaceutical regulations, data privacy and security stand as formidable pillars of compliance. With the growing emphasis on safeguarding sensitive information, pharmaceutical companies face the dual challenge of meeting stringent regulatory requirements while ensuring data integrity and confidentiality.

Parallel Submissions in Canada: A Streamlined Path, or a Different Road Altogether?

The global race to bring new drugs and medical devices to market has fuelled the rise of parallel submissions – a strategy where companies file applications with Regulatory agencies in multiple countries concurrently. A recent study by Tufts Center for the Study of Drug Development found that parallel submissions for new drugs can reduce approval timelines by an average of 9 months. While this approach offers faster approvals and wider reach, navigating the unique landscape of each region is crucial.

Mastering eCTD Submissions: Best Practices for Streamlined Regulatory Approval

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!

Getting Ready for Adoption of eCTD 4.0

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.

Global Regulatory submission and Ideal eCTD software

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. 

4 key factors to select a submission software

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).