FMD K&L offers a variety of services assisting with regulatory information management systems (RIMS)
Regulatory burdens are on the upswing, as exemplified by new requirements for use of EMA’s EudraVigilance Medicinal Product Dictionary (EVMPD) and global Identification of Medicinal Products (IDMP).
FMD K&L applies its expertise in regulatory affairs and technology to help organizations manage their regulatory operations. Our consultants develop short- and long-term strategies to meet submission timelines with minimal impact on day-to-day operations. We add value by improving processes for data capture and submission while enabling sponsors to quickly adapt to changes in regulation. Our services are modular, enabling sponsors to quickly realize the benefit of their investment and select only those services that are most beneficial.
- Screen customization
- Configuration management
- Product validation
- Custom reports
- Third-party application management
- Dictionary management
- Database management
- Application server management
- Application administration