eCTD 4.0
ESG NextGEN
Actively participating in the pilot of the next major version of eCTD, i.e. eCTD 4.0 is the next-gen regulatory standard, enhancing efficiency, lifecycle management, and global compliance.
ESG NextGEN
ESG NextGEN
The FDA's Electronic Submissions Gateway Next Generation (ESG NextGen) is a modernized, cloud-based platform designed to enhance the efficiency, scalability, and security of electronic regulatory submissions.
CDER NextGEN
The CDER NextGen Portal is an online platform developed by the FDA's Center for Drug Evaluation and Research (CDER) to streamline electronic submissions and enhance communication between stakeholders and the agency
EU CTIS
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The EU Clinical Trials Information System (CTIS) is a centralized platform by the EMA for managing and overseeing clinical trials across the EU/EEA. It streamlines submissions, enhances transparency, and ensures regulatory compliance under the EU Clinical Trials Regulation.
HL7 SPL
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HL7 Structured Product Labeling (SPL) is an XML-based standard for submitting drug labelling information to regulatory agencies like the FDA. It ensures consistency, accuracy, and interoperability in the exchange of product and facility data.
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CDISC datasets are standardized formats for clinical trial data, ensuring consistency, interoperability, and regulatory compliance. They include models like SDTM (for raw data) and ADaM (for analysis-ready data) to streamline submissions to agencies like the FDA and EMA