Our experience and proven strategies assist our clients in creating and maintaining real time inspection ready TMFs while also providing guidance, assistance, and support for regulatory submissions necessary to obtain world-wide agency approval.
Our RIM Management Strategy is designed to provide our clients with a complete solution to plan, manage, publish, transmit, archive regulatory submissions and agency correspondence throughout the product’s lifecycle.
Submission Planning and Tracking
Collaborative Authoring
Submission Preparation and Compilation
Submission Transmission
Submission Archiving
Collaborative Authoring
Submission Preparation and Compilation
Submission Transmission
Submission Archiving
Our TMF Management Strategy is designed to analyze, prepare, implement, and audit your TMF to ensure you are ready for your organization’s next audit or agency inspection. Wherever you are in the process, our solution fits your needs.
Step 1 Analysis and Preparation
Step 2 TMF Management Process Implementation
Step 3 TMF Finalization
Step 4 TMF Mock Audit
Step 5 TMF Audit/Inspection
Our R&D Systems Implementation services is designed to align with the vendors implementation strategy to provide clients with a complete solution: a brand-new system, process, and our expert project resources.
Roadmap and Strategy
Project Governance and Strategy
Change Management
Industry’s best practices during system configuration activities
Process development and training
Validation Support
Data Migration Support
Go-Live Strategy Planning
Release Management
User Support
