Freyr Digital

In today's highly regulated business landscape, organizations face the formidable challenge of managing an ever-growing volume of documents to ensure Regulatory compliance with diverse standards and regulations. To navigate through complexities such as document overload, compliance costs, increased audit scrutiny, etc., many businesses are adopting Regulatory Document Management Systems (RDMS). This blog explores how RDMS can streamline compliance efforts, improve productivity, and reduce risks, ultimately driving organizational efficiency.

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!

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.

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.

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.

Life sciences is a highly regulated industry, full of sensitive information that is required to be maintained efficiently. Documents are the backbone of any life sciences segment since it establishes the quality of processes and assurance of safety. The growing volume of documents in organizations exponentially increases the demand to replace traditional and manual documentation practices to reduce time, effort, and errors. In such scenarios, the absence of a proper Document Management System (DMS) increases the chance of misplacing critical documents and tracking changes significantly.

Pharmacovigilance safety database systems are crucial in today’s Life Sciences world, where ensuring data quality is integral to help simplify the process of managing medical and scientific literature. Literature monitoring, an important process in drug safety vigilance, offers an end-to-end approach for literature surveillance in pharmacovigilance. Such processes bring a streamlined and compliant approach to the organization. Automating the process will bring many benefits, including efficiency and accuracy without additional risks.

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.