10 Small Submissions
No more than 10 Documents per submission
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.
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 Electronic Common Technical Document (eCTD) has become the golden standard for drug regulatory submissions worldwide, and with the advent of eCTD 4.0 in 2022, a new chapter of innovation began. While this latest version boasts remarkable benefits like heightened efficiency and precision, it also ushers in unique challenges for countries transitioning to this cutting-edge format. In this blog, we'll embark on a journey to uncover these challenges, as the world navigates the transformative waters of eCTD 4.0.
In today's rapidly evolving pharmaceutical landscape, regulatory compliance plays a pivotal role in ensuring medicinal products' safety, efficacy, and timely availability. Regulatory submissions are critical to this process, requiring pharmaceutical companies to navigate complex frameworks and meet stringent requirements.
Imagine working on a new drug to treat a devastating disease. After years of hard work, you've finally gathered the data you need to submit a regulatory submission to the FDA. But then, you realize that your electronic records and eSignatures don't comply with 21 CFR Part 11. This is a scenario that no one wants to find themselves in. The world of regulatory compliance is complex and ever evolving. With new regulations being introduced all the time, it can be difficult for businesses to keep up.
In the dynamic world of pharmaceuticals, the role of real-world data (RWD) and real-world evidence (RWE) is becoming more pivotal. These tools provide a bridge between the controlled environment of clinical trials and the real-world complexities of patient care. Several pharmaceutical companies have successfully used RWD/RWE to support their regulatory submissions.