In regulatory submissions, the difference between a flawless, on-time submission and one riddled with delays often comes down to one key factor: communication. When teams aren’t aligned, and information is scattered, even the most well-planned submissions can become chaotic. But what if you could centralize communication and data exchange to avoid these pitfalls entirely?

As we step into 2024, the pharmaceutical and life sciences industries are rapidly transforming. A growing demand for regulatory affairs (RA) professionals is evident across the pharmaceutical industry, consultancy firms, clinical research organizations, and regulatory agencies. Regulatory affairs professionals are at the forefront, ensuring compliance and market access for groundbreaking therapies. To thrive in this dynamic environment, here are the top five skills every regulatory affairs professional should master:

The idea of electronic regulatory submissions for pharmaceuticals predates the eCTD tool itself. In the late 1980s, initiatives such as CANDA (Computer-Aided New Drug Application) were explored by the US FDA (Food and Drug Administration) and European agencies. These early efforts sought to enhance efficiency and data access for reviewers.

Electronic Common Technical Document (eCTD) submissions are a cornerstone in the life sciences industry, enabling streamlined and efficient regulatory processes. This is the reason companies globally have mandated the use of eCTD. However, the creation and submission of eCTDs come with their own set of challenges. In this comprehensive guide, we will explore these challenges and how regulatory software can help overcome them, ensuring compliance and maximizing return on investment (ROI).

The world of pharmaceutical regulations is about to get a major upgrade with the implementation of eCTD 4.0. This standardized format promises a smoother journey for new drug applications submitted to regulatory bodies. But for companies eyeing a slice of the $141.5 billion Japanese pharmaceutical market, there's a crucial twist – Japan is accelerating the adoption timeline!

Below is an analysis of these highlights:

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.