Regulatory Information Management Services
- Continuous Surveillance of Health authority websites (USFDA, Health Canada, TGA, EMA, EDQM, ANVISA, NPRA and various national authorities across EU and other regions)
- Capturing latest regulatory updates, alerts, notifications, circulars, announcements.
- Surveillance of other allied websites viz. WHO, Uppsala monitoring centre (UMC), CMDh, HMA, ICH, MedRA, trade associations, press release
- Advisory meetings
- Keeping customers abreast of new, updated, revised or emerging regulatory requirements from a global- regional to a local level
- Notify stakeholders (Client site/ internal) and decision makers to refine or redefine strategies to manage potential risks or market access ease.
- Broadcasting RI information through daily/ weekly/ biweekly mailers, newsletters towards establishing an effective way of communication with customers, tracking any actions for impact across departments (Regulatory and other functions)
- RI Consulting on new initiatives focus on changes to customer’s internal processes, policies and standards based on emerging regulatory intelligence or in the new product development aspects, content modules or services
- Complete support for cross functional departments in providing regulatory intelligence (Customer)
Description on our experience on the above tools for RI & RIMS (Regulatory Information Management Software)
Our experts have In-depth knowledge of IT systems used with regulatory, QA and compliance, PV/safety, clinical and quality (validated systems) Consulting and advisory services in developing the most apt tools for RI, tracking, and maintaining the database/ products information across markets and categories.
Most efficient and easy cloud-based Regulatory intelligence tools and software to identify, gather, populate, and update all HA released information by assessing available/ current regulations, replacing older and reviving the latest RI info on records
