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.
What We Offer
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