ORTHOGONAL·CONCEPT
Early Stage Formulation and Drug-Device Compatibility Experts
ORTHOGONAL·CONCEPT
Early Stage Formulation and Drug-Device Compatibility Experts
Who We Are
Orthogonal Concept is a contract laboratory and consulting group that specializes in pharmaceutical stability, combination medical devices and the interactions between devices and pharmaceuticals. We work with both proteins and small molecules.
Our members have a history of success in:
- Pharmaceutical Science
- Combination Device Optimization for Drug Compatibility
- Simulated Use, Drug - Device Compatibility Studies
- CMC Chemistry Submissions
- Technical Interactions with Pharma and the FDA (CDRH, CDER, CBER)
- Non-Clinical Study Device Analysis and Troubleshooting
- Root Cause Analysis
- Analysis of Returned Clinical Devices
- Grant Applications
What We Do
Orthogonal·Concept will support your pursuit of feasibility data, design verification, grant applications, and regulatory approval.
We have substantial drug-device compatibility testing and troubleshooting capability. This includes on-site simulated use and in-house analysis of most pharmaceutical and mechanical samples. We are also able to inspect, document and test certain biohazard clinical returns.
Orthogonal·Concept has helped several engineering startups to build submission packages, design and perform feasibility studies, vet materials changes and respond to FDA observations. We are an experienced liaison for device startups in their interaction with the FDA and/or big Pharma.
Bridge the Drug - Device Divide
The Orthogonal Team knows how to bridge the gap between competing drug stability and device performance requirements. We understand the perspectives of both CDRH and CBER. We can help your development program meet the requirements of both agencies to bring a safe and effective product to market.
Orthogonal·Concept
2380-G Camino Vida Roble, Carlsbad CA 92011