How an eCTD Software Solution Simplifies Regulatory Submissions Pharmaceutical regulatory submissions have evolved from paper-based chaos to highly structured electronic formats. The electronic Common Technical Document (eCTD) has become the global standard for submitting dossiers to agencies like the USFDA, EMA, Health Canada, PMDA, and others. But with stringent formatting rules, metadata tagging, version control, […]
With Brexit transforming the regulatory landscape in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has taken strategic steps to streamline drug approvals. One of the key post-Brexit regulatory pathways is the International Recognition Procedure (IRP), which allows faster approval of medicines already authorized by trusted reference regulators. To support this procedure, the […]
In regulatory affairs, eCTD submissions aren’t just about compiling documents and hitting “send.” They’re about precision, timing, and compliance — and when something goes wrong (because it often does), the strength of your support system determines whether you succeed or scramble to recover. Let’s dive into why support isn’t optional — it’s essential — and […]
When it comes to eCTD dossier submissions, success isn’t just about getting approvals — it’s about getting them approved faster, smoother, and without errors. To achieve that, four pillars are essential: simplified submissions, cost-effectiveness, user-friendliness, and global support. Let’s break down why these four factors are the ultimate formula for success — and how KnowledgeNET […]
Let’s face it — regulatory submissions are complicated enough. The last thing you need is a complex system making things harder. When your software isn’t designed with simplicity in mind, the road to success becomes a lot longer — and bumpier. Let’s break down exactly what can go wrong when your system isn’t simple to […]
Singapore’s Adoption of eCTD: A New Era in Regulatory Submissions The Health Sciences Authority (HSA) of Singapore has embarked on a significant transformation in its regulatory submission process by adopting the electronic Common Technical Document (eCTD) format. This initiative aims to streamline the submission and review of therapeutic product dossiers, aligning Singapore with international standards. […]
When it comes to regulatory submissions, choosing the right eCTD software partner can make all the difference. Many vendors sell eCTD software, but true partners go beyond just providing a tool—they offer expertise, customization, integration, and long-term support to ensure regulatory success. This is where industry leaders like Sarjen Systems stand apart. Why an eCTD […]
In today’s fast-paced regulatory environment, efficiency and accuracy are key. When it comes to eCTD publishing, manual processes can cause delays, increase human error, and make it hard to meet deadlines. But with the right eCTD publishing tools, automation is the game-changer your team needs. Let’s explore three top use cases where automation can dramatically […]
If you’re working in regulatory submissions, you know how important it is to get the details right. When it comes to electronic Common Technical Document (eCTD) submissions, the software you use plays a big role in making the process smooth. But have you ever stopped to think: could your eCTD viewer software actually be causing […]
Managing regulatory submissions can feel like solving a big puzzle. With different rules for each country, lots of document formats, and tight deadlines, the process can get overwhelming. That’s where KnowledgeNET comes in—a powerful dossier software that makes regulatory submissions easier and faster. Why KnowledgeNET Is the Best Choice KnowledgeNET isn’t just software; it’s your […]