Consulting Services
Canyon Labs offers a breadth of expertise to help you bring your products to market. You can be sure that our engineering consulting, regulatory consulting, and scientific consulting services are up to the task. No matter how big or small your need is, our team of experts will guide you through the process step-by-step.
Our capabilities range from site qualification, process development, and lean manufacturing consultation to sterility analysis and stability consultation. Refer to our full catalog of services below to see how Canyon Labs can help you.
Not sure what you need? We can help with that, too.
Contact an ExpertRegulatory Consulting
Meeting regulatory standards is a complex and arduous process, so let us take on the burden for you. Our team of seasoned regulatory professionals has managed hundreds of projects requiring expert guidance in the following areas:
Annual Regulatory Reports
Clinical Expert Reports
Design Dossier Development and Management
Device Classification
Device Labeling and Marketing Guidance
FDA Pathways
Investigational Device Exemption
Medical Device Registrations and Listings
Medical Device Submissions (510k, De Novo, Pre-Market Approvals)
Q-Submissions
Regulatory Life Cycle Management
Report of Prior Investigation
Software Regulatory Guidance
Technical File Development and Management
US and International Regulatory Strategies
Use of Real-World Evidence
Verification and Validation Testing Guidance
Request for Designation (RFD)
Scientific and Technical Consulting
Our team has designed, validated, and operated multiple labs, so we know what it takes. These are some of the scientific and technical services that we can help you with:
Scientific
Interpreting Test Results
Microbial Load Assessment
Chemical Compatibility Assessment
Cleaning Validation Assessments, Protocols, and Test Methods
Chemical and Microbial Stability Assessments and Protocols
Aseptic Processing and Terminal Sterilization Assessments, Protocols, and Test Methods
Quality Engineering
Facilities Qualifications
Method Transfers and Qualifications
Process Validation Assessments and Protocols
Measurement System Analysis and Validation
Process Capability Assessment and Implementation
Sampling Plan Assessments and Implementation
Mechanical Engineering
3D Printing
Product, Equipment, and Packaging Prototyping
Tolerance/Specification Development and Assessment
FAT and SAT Protocols
Facility Design and Controls
Lean Manufacturing
New Process Development and Implementation
Existing Process Assessments and Improvements
Process and Equipment Sourcing
Preventative Maintenance Development, Assessment, and Implementation
In-line Measurement System Development, Assessment, and Implementation
Packaging Integrity/Stability Assessments and Protocols