Regulatory Software

In today's rapidly evolving business landscape, organizations across life science industries face stringent Regulatory requirements. Compliance with these regulations is not only crucial for legal and ethical reasons but transforming end-to-end operations with a unified RIMS suite. With Regulatory Information Management System (RIMS), businesses now have a powerful tool to ensure compliance and streamline their Regulatory processes. In this blog, we will delve deeper into the role of Regulatory Information Management in unlocking the Regulatory landscape for compliance.

The process of submitting Regulatory documentation to Health Authorities can be complex and time-consuming. Many organizations partner with a vendor that offers a submission tool to ease this process. With so many options in the market, it can be difficult to know who the right strategic partner is for your submission requirements.

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.

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.

Regulations stand crucial for any industry that functions in the Life Sciences domain, which is the third most heavily regulated sector after the Aviation & Financial sectors. Non-compliance with regulations comes at a high cost – the patients’ lives, heavy economic penalties, or loss of reputation. But challenges to this sector comes from various areas.

On July 28, 2022, the EMA released an incremental update to the IDMP-SPOR implementation guide (IG). The latest version, 2.1.1, addresses a few gaps in product data definition, including corrections and clarifications.

The new version enables web-based forms to replace the existing electronic application forms (eAF), making them more efficient. The web-based forms project is called DADI (Digital Application Dataset Integration), and its implementation is planned to start in October 2022 with an initial web form for variation procedures only.

Introducing innovative products across global marketplaces is imperative for life sciences companies to ensure profitability and maintain their presence in the market. Regulatory compliance and authorizations being the key factors behind any winning launch, inadequate Regulatory information can trigger an increase in costs and time-to-market.

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.

The post-pandemic world is realizing that the intersection of technology and a traditional way of doing business already exists with us. The highly competitive nature of our business only exemplifies the need of incorporating innovative technologies to augment and support customers in the ever-evolving Regulatory landscape. Trends show that the global automation market, especially in the life sciences industry, is poised to grow close to $2.5 bn by 2025 with a CAGR of approximately 7.5%.