Your Consulting Resource from Development to Launch
At Canyon Labs, we want to be more than just a test laboratory. We want to support your project throughout the full development cycle and into production by leveraging our team’s extensive technical background.
Our consultants provide a wide range of services to compliment our compliance testing. This includes regulatory & quality, packaging engineering, sterilization validations, biocompatibility risk assessments, and more.
By providing consulting services, Canyon Labs can truly be your one-stop-shop to support your submission and launch.
Regulatory & Quality 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:
- Medical Device Submissions (510(k), PMA, De Novo)
- EU MDR Compliance & Requirements
- FDA Compliance & Requirements
- Labeling & Marking Guidance
- Q Submissions (Pre-Submissions)
- Design History File (DHF) Gap Analysis
- Risk Assessments (PHA, FMEA, RMP, RMR)
- Sample Size Assessments & Selections
Packaging Consulting
Your product is only as good as it’s package. Our team of medical & pharmaceutical packaging engineers can serve as your personal experts to handle anything from design to process implementation. Let us help speed up your next packaging project.
- User-Centric Package Design & Development
- Design for Manufacturability & Scalability
- Equipment Procurement
- Validation Protocol & Report Authorship
- Failure Root Cause Analysis
- EU Directives
- USP, PDA, and ICH Guidelines
- Sustainability Design & Directives
Sealing Process Validations
- Design of Experiments (DOE’s)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Process Qualification (PQ)
Thermal Solutions
Ensuring products or drugs stay within a specified temperature range during shipment can be difficult to design, scale, implement and validate. Let our experts help create your plan from ideation to shipment.
- Cold Chain Packaging Design & Development
- Sustainability Focused Packaging Re-Design
- Thermal Profile Development
- Protocol Authorship & Development
- Cold Chain Validation Testing per ISTA 7D & 7E & Custom Profiles
Sterilization Consulting
Developing an effective sterilization process is a critical part of every sterile medical device and pharmaceutical product. Each process must by validated to ensure your product remains sterile throughout its lifecycle and is safe for patient use. Our team of experts and partners can help guide you in the following areas:
- Sterilization Modality Selection (EtO, E-Beam, Gamma, X-Ray, VHP, CD, etc.)
- Sterilization Cycle Development & Feasibility
- Sterilization Validation Protocol / Report Authorship
- Management and Execution of Microbiological Testing for Sterility
- Dose Mapping
- Dose Audits
- Biological Risk Assessments (BRA)
Contract Sterilization
Canyon labs leverages preferred partnerships to meet your needs for contract sterilization.
Electron Beam (E-Beam) Sterilization
Canyon Labs leverages a preferred partnership for E-Beam Sterilization.
Ethylene Oxide (EtO) & Steam Sterilization
Canyon Labs leverages a preferred partnership with Steritec for EtO & Steam Sterilization.