The Most Effective Strategies

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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.

Regulatory Submission Management and Publishing

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

TMF Management Strategy

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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

R&D Systems Implementation

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