Freyr SUBMIT PRO

In today's rapidly evolving life sciences industry, Regulatory submissions play a crucial role in ensuring the safety, efficacy, and compliance of medicinal products. As the industry faces increasing complexities and global regulations, it is essential for life sciences companies to adopt innovative solutions that streamline the Regulatory submission process. In this blog, we will explore the significant contribution of import and integration functionality in Regulatory submission software, and how they drive innovation in the life sciences industry.

The Regulatory writing and publishing segment claimed a dominant 36.6% revenue share in 2022 (GVR report), propelled by outsourcing in the biopharmaceutical and medical device industries. Staying ahead in the fast-paced world of regulatory submissions is paramount. Embracing game-changing technologies and keeping updated yields faster approvals, fewer errors, and heightened Regulatory compliance. Explore how an updated submission software revolutionizes the regulatory landscape, unlocking untapped potential and driving unprecedented success.

As Regulatory landscapes evolve, countries worldwide are embracing the adoption of electronic Common Technical Document (eCTD) submissions to streamline their Regulatory submissions processes. One such country that will soon be venturing into the realm of eCTD submissions is Singapore. This transition would mark a significant milestone in their regulatory framework, enabling efficient and standardized submission processes, fostering collaboration, and embracing digital transformation in regulatory affairs. 

Small and medium-sized life science companies are the backbone of the Healthcare industry, but Regulatory hurdles often hamper their potential for ground-breaking innovation. These companies face an uphill battle to bring their products to markets, with limited resources and expertise in navigating the complex Regulatory landscape. However, by adopting effective strategies and seeking expert guidance, they can overcome the odds and emerge as leaders in their field.

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.