VALIDATION & COMPLIANCE SERVICES
EXPERTS AT WHAT WE DO
We have extensive knowledge in Regulatory Compliance with a focus on the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Our team brings quality knowledge, validation expertise, and project management skills to your projects. Validations and Compliance solutions can be provided in the conventional way and using a fixed price outsourcing model. With a fixed price outsourcing model, we can provide project continuity and accountability in your current operations and improve resource utilization. We leverage our vast worldwide regulatory compliance knowledge and combine it with packaging and manufacturing process expertise to guarantee and deliver the Ultimate Results.
Ultimate Development & Execution (U-DE)
How Work Gets Done
- Project Documentation Development in House
- Document Approval Time Saving (DocsTrack)
- Protocol Execution
- Validation
Project Management
The Key to All
- Completion
- Execution
- Initiation
- Control & Monitoring
- Plan
Quality
- Investigations
- Risk Assessment
- Change Control
- Batch Records
- SOP
- Complaints
- Data Integrity
- CAPA
- Audits
- Periodic Reviews
- Among Others
“The use of these resources was invaluable to the completion of the IQ/OQ. Both resources were not only excellent from the validation
perspective, but their knowledge of the system operations, screens, connectivity & expected behavior added a new degree of
efficiency…”
