Overview
Our regulatory and technology experts have the unique ability to increase collaboration between and within departments allowing data sharing and process optimization across organizational silos. This significantly lowers the cost of compliance by reducing data management tasks. Integrating the data on a single platform allows instant access and harmonization of the data related to the active ingredients, supply chain, sites and facilities. This is in consonance with ISO standards, IDMP, HL7 standards and EMA guidance on SPOR.
Our technology experts have capability to develop software/tools which leverage Automation and Artificial Intelligence for data identification, classification, and reporting. In addition, we have hands-on experience on off-the-shelf software to address end-to-end Regulatory requirements.
- Regulatory Information Management (RIM) Systems
- Data extraction from multiple sources using Automation/Artificial Intelligence
- Software as a Medical Device (SaMD) services driven by Artificial Intelligence and Machine Learning
- Software/Tools:
- Document Level Publishing Tools
- Submission Level Publishing/eCTD Publishing Tools
- eCTD Validator
- eCTD Viewer
