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.

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Regulatory 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:

  • 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

You're not expected to know everything. Rely on us to help you get your job done efficiently and effectively.

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