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 […]
In the competitive world of pharmaceuticals, the ability to publish eCTD dossiers quickly and accurately can be the difference between securing a market lead and falling behind. Imagine being able to reduce your dossier publishing time by 60%! This isn’t just a dream; with the right tools, it’s entirely achievable. Enter KnowledgeNET, where innovation meets […]
Is your current eCTD viewer helping you manage regulatory submissions efficiently, or is it slowing you down? In the ever-evolving pharmaceutical landscape, having a reliable, intuitive tool is essential to keep up with complex submissions. But does your system give you the full picture? With KnowledgeNET’s eCTD Life Cycle Viewer, you gain more than just […]
What is the CEP 2.0? From the September 2023 this new CEP2.0 will be implemented. Manufacturer and the various organization want to know about what cep2.0 Cep2.0 is new look or the future cep. 1.What will change in the CEP2.0 As part of the implementation of the CEP 2.0, some changes are introduced, which affect […]
PRIME is a European Medicines Agency (EMA) initiative to increase assistance for the development of medicines that address an unmet medical need. Through PRIME, the Agency provides early and proactive support to drug developers to maximise the production of reliable data on a medicine’s benefits and risks and to allow accelerated assessment of drug applications. […]
The FDA is proposing to establish norms for a non-prescription medication with an additional condition for non-prescription use (ACNU). If implemented, the proposed rule would establish requirements for a non-prescription drug product with an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers who are not […]