Hawai’i Regulatory Services

Hawai'i Regulatory Services is your one-stop resource for today's cutting-edge companies in search of assistance in navigating the requirements of regulated industry.  Whether your company designs, develops, manufactures or distributes regulated products, you often need the help of an outside resource to ensure you are on-track. 

Developing and maintaining medical products, nutritional supplements and food manufacturing services in the market is a complex and challenging task. At every step in the process, there is the potential that regulatory requirements will become barriers to the marketplace or to continuing services. We are available to help.

• FDA Post-inspection response strategy development

• FDA 483 and Warning Letter Remediation Assistance

• 510(k) Medical Device Submissions
• CE Mark Technical File Preparation and Submission

• GAP Analysis (where you are with compliance vs. where you need to be)
• FDA Quality System Tune-up Compliance Audits for Medical Device, Nutritional Supplement and Food Manufacturers
• ISO 13485 Audits and Consulting
• HACCP Plans and Assessments
• Contamination Control Consulting
• Quality Control Strategy Development
• Environmental Monitoring Development and Consultation
• SOPs, Technical Writing, Protocol Development
• Quality System Library Leasing and Maintenance
  
• Complaint Management Assistance/Remediation
• Quality Systems Development
• Supplier Audits
• Sterility Control & Clean room SOP Development
• Clinical Laboratory Certification Assistance
• Small Business and Start-Ups Regulatory Mentoring
  

                COMPLETE THE CONTACT FORM OR CALL OUR OFFICE: 808.238.2292 FOR ADDITIONAL INFORMATION