Client Overview
A pharmaceutical company developing a novel combination product for a common health condition engaged ClariMed to ensure successful FDA submission. With parallel clinical trials underway and compressed regulatory timelines, they needed comprehensive human factors documentation and validation completed without compromising quality or compliance.
Client Overview
A pharmaceutical company developing a novel combination product for a common health condition engaged ClariMed to ensure successful FDA submission. With parallel clinical trials underway and compressed regulatory timelines, they needed comprehensive human factors documentation and validation completed without compromising quality or compliance.
Client Overview
A pharmaceutical company developing a novel combination product for a common health condition engaged ClariMed to ensure successful FDA submission. With parallel clinical trials underway and compressed regulatory timelines, they needed comprehensive human factors documentation and validation completed without compromising quality or compliance.
Meeting Aggressive FDA Timelines While Maintaining Regulatory Excellence
Challenge
The client faced a critical convergence of challenges that threatened their market entry timeline:
Compressed regulatory deadline requiring simultaneous development of multiple HFE deliverables while running validation studies
Evolving product labeling that couldn't delay validation testing, requiring adaptive study design
Comprehensive documentation needs including KUPS, URRA, IFU optimization, and validation protocol—all required for FDA submission
Solution
ClariMed deployed an innovative "parallel processing" approach that transformed a linear timeline into concurrent workstreams:
Strategic Resource Allocation: Four-person specialized team with dedicated ownership—protocol lead, KUPS specialist, URRA expert, and project oversight—enabling simultaneous document development rather than sequential processing
Adaptive Study Design: Developed flexible validation protocols that could accommodate labeling refinements without compromising data integrity or requiring re-testing
Real-Time Quality Management: Project lead managed background activities (GDP compliance, data entry, report preparation) during study execution, ensuring zero downtime between phases
Proactive Client Partnership: Weekly strategic check-ins and progress dashboards kept stakeholders aligned, enabling rapid decision-making and preventing bottlenecks
Results
Our parallel processing approach delivered exceptional outcomes that exceeded client expectations:
Accelerated Timeline: Delivered complete HFE and validation reports 2+ weeks ahead of schedule, providing buffer for FDA submission
First-Pass Quality: Minimal revisions required on all deliverables, demonstrating deep regulatory expertise
Expanded Partnership: Success led to additional engagements including risk management planning and residual risk assessments
Strategic Value: Enabled client to maintain clinical trial timelines while completing HFE requirements, preventing costly delays
The client expressed high satisfaction with our work and has engaged us for multiple follow-on projects, citing our ability to manage complex, parallel workstreams while maintaining exceptional quality as instrumental to their FDA submission success.
Ready to Accelerate Your FDA Submission Timeline?
Don't let human factors requirements delay your market entry. Our parallel processing approach and deep regulatory expertise can help you meet aggressive timelines without compromising quality.
Meeting Aggressive FDA Timelines While Maintaining Regulatory Excellence
Challenge
The client faced a critical convergence of challenges that threatened their market entry timeline:
Compressed regulatory deadline requiring simultaneous development of multiple HFE deliverables while running validation studies
Evolving product labeling that couldn't delay validation testing, requiring adaptive study design
Comprehensive documentation needs including KUPS, URRA, IFU optimization, and validation protocol—all required for FDA submission
Solution
ClariMed deployed an innovative "parallel processing" approach that transformed a linear timeline into concurrent workstreams:
Strategic Resource Allocation: Four-person specialized team with dedicated ownership—protocol lead, KUPS specialist, URRA expert, and project oversight—enabling simultaneous document development rather than sequential processing
Adaptive Study Design: Developed flexible validation protocols that could accommodate labeling refinements without compromising data integrity or requiring re-testing
Real-Time Quality Management: Project lead managed background activities (GDP compliance, data entry, report preparation) during study execution, ensuring zero downtime between phases
Proactive Client Partnership: Weekly strategic check-ins and progress dashboards kept stakeholders aligned, enabling rapid decision-making and preventing bottlenecks
Results
Our parallel processing approach delivered exceptional outcomes that exceeded client expectations:
Accelerated Timeline: Delivered complete HFE and validation reports 2+ weeks ahead of schedule, providing buffer for FDA submission
First-Pass Quality: Minimal revisions required on all deliverables, demonstrating deep regulatory expertise
Expanded Partnership: Success led to additional engagements including risk management planning and residual risk assessments
Strategic Value: Enabled client to maintain clinical trial timelines while completing HFE requirements, preventing costly delays
The client expressed high satisfaction with our work and has engaged us for multiple follow-on projects, citing our ability to manage complex, parallel workstreams while maintaining exceptional quality as instrumental to their FDA submission success.
Ready to Accelerate Your FDA Submission Timeline?
Don't let human factors requirements delay your market entry. Our parallel processing approach and deep regulatory expertise can help you meet aggressive timelines without compromising quality.
Meeting Aggressive FDA Timelines While Maintaining Regulatory Excellence
Challenge
The client faced a critical convergence of challenges that threatened their market entry timeline:
Compressed regulatory deadline requiring simultaneous development of multiple HFE deliverables while running validation studies
Evolving product labeling that couldn't delay validation testing, requiring adaptive study design
Comprehensive documentation needs including KUPS, URRA, IFU optimization, and validation protocol—all required for FDA submission
Solution
ClariMed deployed an innovative "parallel processing" approach that transformed a linear timeline into concurrent workstreams:
Strategic Resource Allocation: Four-person specialized team with dedicated ownership—protocol lead, KUPS specialist, URRA expert, and project oversight—enabling simultaneous document development rather than sequential processing
Adaptive Study Design: Developed flexible validation protocols that could accommodate labeling refinements without compromising data integrity or requiring re-testing
Real-Time Quality Management: Project lead managed background activities (GDP compliance, data entry, report preparation) during study execution, ensuring zero downtime between phases
Proactive Client Partnership: Weekly strategic check-ins and progress dashboards kept stakeholders aligned, enabling rapid decision-making and preventing bottlenecks
Results
Our parallel processing approach delivered exceptional outcomes that exceeded client expectations:
Accelerated Timeline: Delivered complete HFE and validation reports 2+ weeks ahead of schedule, providing buffer for FDA submission
First-Pass Quality: Minimal revisions required on all deliverables, demonstrating deep regulatory expertise
Expanded Partnership: Success led to additional engagements including risk management planning and residual risk assessments
Strategic Value: Enabled client to maintain clinical trial timelines while completing HFE requirements, preventing costly delays
The client expressed high satisfaction with our work and has engaged us for multiple follow-on projects, citing our ability to manage complex, parallel workstreams while maintaining exceptional quality as instrumental to their FDA submission success.
Ready to Accelerate Your FDA Submission Timeline?
Don't let human factors requirements delay your market entry. Our parallel processing approach and deep regulatory expertise can help you meet aggressive timelines without compromising quality.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
