FMD K&L proprietary technology solutions help you stay ahead of ever-increasing safety and compliance challenges
Every year, global product development faces fresh challenges and higher regulatory hurdles. We provide strategies, services, and solutions to help you clear every compliance hurdle.
Our offering includes:
- SafetyINTEGRATOR: seamlessly integrates regional contact center databases with the global safety database
- QPLUS: a software solution assisting with document review based on a checklist of key parameters that qualify a document as ready for submission; applicable to a variety of documents, such as aggregate reporting of safety data; provides ability to track key performance indicators & furnish real-time feedback/analysis
- Regulatory Information Management System (RIMS): a modular set of services to improve processes for data capture & submission while enabling sponsors to quickly adapt to regulatory changes
- SafetyTEST: a software solution that surveys your safety system, monitors expedited reports, where they are sent & delivers daily alerts highlighting instances of underreporting and overreporting, all without affecting the validation state of your safety system