First and foremost, we are a consulting firm specializing in regulatory affairs and quality systems for the medical device, biotechnology and pharmaceutical industries.

During the course of our regulatory/quality projects we come across rising stars and established, seasoned professionals, many of whom are not actively seeking another job but would be interested in a great career move.

With our clear regulatory/quality focus, we are intimately familiar with the caliber of staff that you will need to succeed and can provide great insight into finding the right candidate (or sometimes more importantly - avoiding the wrong one).

The partners/associates of the Horizon Phoenix Group offer:

• An enviable track record of getting it right the first time, every time!
• Quality System Experience covering the entire quality spectrum including ISO 9001:2000; ISO 13485:2003; current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
• Product experience spanning the spectrum from high volume disposables, implants, in vitro diagnostic test kits, artificial organs and drug/device combinations.
• Accredited Consultants and Auditors
• Experience gained from 3000+ Registration and Surveillance Audits, with no major non-conformances.
• Experience gained from over 600 clients on CE Marking, CMDCAS, FDA, and Quality System Registrations.

Benefit from Horizon Phoenix’s professional associations, memberships, worldwide contacts, training, and education including:

• Established strategic partnerships and working relationships on every major continent and with every major regulatory agency.
• Key relationships with leading Notified Bodies, Testing Laboratories, Quality System Registrars and Medical Institutions worldwide.
• Seminar leaders who have presented at such industry-recognized events as Biotechnica America 2003 in Monterey (California), conferences on Pharmaceutical/ Biopharmaceutical and Medical Devices in Asia, Asia BioMed - Singapore, and QualCon 2003 - Australia.
• Leaders in industry-related research on such topics as: Standards, Quality Systems, and Product Certification as part of the Federal Regulatory Process, National and International Standards Systems, Value and Market Access through Effective Conformity Assessment, and Using Quality Systems to Your Advantage, and collaboration on 100+ National Standards and International ISO and IEC Standards on medical devices and biotechnology.
• A strong network of expertise allows us to provide our clients with the most current and leading edge interpretations of directives, standards, and regulations, ensuring your product testing is always appropriate, cost-effective, and up-to-date!
• World-renowned expertise in European Union, USFDA, Canadian, and Asian regulatory issues.
• High quality scientific expertise in: FDA product review, Clinical Trials, protocol development, current Good Laboratory Practices, current Good Manufacturing Practices, drug/device combinations, leading the introduction of new technology, and upscaling products from design to full manufacturing for a wide range of medical devices including nuclear power generation.
• Qualified professionals including Accredited Medical Devices Lead Auditor for various regulatory agencies and notified bodies, as well as Master’s and Doctorate level degrees from leading educational institutions.
• Qualified worldwide services to meet global needs, as well as the provision of quality local solutions that meet specific organizational needs.

The Horizon Phoenix Group makes Quality Systems an investment in your future!