USFDA Market Clearance gives you access to the single largest, most valuable most important market place. We can get you into the market place faster and more cost effectively with timely services such as:

Market Access Submissions

• 510K preparation, monitoring and submissions
• Substantial Equivalency Determination
• Significant Change Determination
• Premarket Approval (PMA)
• Organization and conduct of Clinical Investigations
• Investigational Device Exemptions (IDE)
• USFDA presubmission consultation, determination
  and/or agreement meeting
• Drug/Device Combinations
• In Vitro Diagnostic Devices
• CLIA Waivers and Submissions

USFDA Compliance

• Inherent Safe Design of devices/products
• Unimpeachable Design Transfer Validation
• Comprehensive Design History Records
• Implementation of General Controls and/or Special Controls
• HACCP based in process tests, checks and final product release
• Process Validation
• Software Validation
• current Good Manufacturing Practices (cGMPs)
• current Good Laboratory Practices (cGMPs)
• Compliance with Consensus and/or Performance Standards
• Implementation of the Quality System Regulation (USFDA QSR)

Virtual World Wide Market Access

One design process, one series of product testing, multiple regulatory applications equal virtual worldwide market access. Horizon Phoenix experts can make sure all your efforts are focused on the broadest possible market access. Don’t repeat tests, inspections, clinical investigations in fact don’t waste a single effort. One process, one quality system, one design, one series of tests, that apply to every market where you want to sell your product, let Horizon Phoenix show you how!

USFDA Mock QSIT Inspection

Horizon Phoenix expert auditors can prepare your documentation, processes and people for your USFDA Inspection through a Mock Audit. During three days on site and with two days of off site preparation we will inspect like the FDA only we provide you with corrective/preventive actions to bring you into full compliance and we also teach you staff how to effectively and ethically interact with the FDA Inspectors. Never fear an inspection again!

Help! The USFDA is mad at me!

Nothing is as disconcerting, expensive and time consuming as an FDA 483, Warning Letter, Field Correction or Recall. When you bring Horizon Phoenix experts in to assist you in these situations three very important things happen.

1) You can go back to running your company, making safe products and expanding your market share. Second,

2) The issues are not only adequately and appropriately addressed, but we also ensure the corrective/preventive actions implemented are effective and achieve desirable results. But most importantly,

3) We restore your working relationship with USFDA.

You cannot talk your way out of these kinds of problems – you need solid, effective actions that reflect great integrity on your operations and product line. Horizon Phoenix experts have been there before, we know what to expect, we know what works and what doesn’t.

Horizon Phoenix experts, 25 years experience in putting clients on the cutting edge and keeping them off the cutting block!

Ask Us How!...