Sometimes you just need a little guidance to get things done. With the Online Consultant you get specific answers to solve your problems quickly and efficiently.

Why pay for a consultant’s entire day (and their travel expenses too) when all you need is some validation that you are going in the right direction.

• It’s not the skill in your field that is lacking – sometimes you just need a jumpstart! You are a skilled RA/QA manager surrounded by demands from every direction and what you really need is a little jumpstart now and again that can provide that quick fix. Tap into our knowledge and pull out one of our guideline documents.
• Are you a start up company or still so new to the business that what you could really use is a little help now and again? With a careful eye on your cash flow you are seeking advice from an expert that won’t steer you wrong.
• You are just doing feasibility studies for a new product line or a new application and it is just too early to bring on a consultant but you could still need a little help.
• You are a small company trying to keep your costs in line.
• Maybe you are a large company with very dynamic needs and it is just too difficult for your RA/QA staff to do everything.
• In the past, you may have had a poor result using a consultant
  and while you need some guidance, you are very concerned about bringing another consultant in.
• Perhaps it is just too early or the project too small for a consultant but you still need advice for your design and development efforts.
• With the Online Consultant you can count on consistent advice.
• You want the job done right.

Why Horizon Phoenix?

First and foremost, we are a consulting firm specializing in regulatory affairs and quality systems for the medical device, biotechnology and pharmaceutical industries. Between our 37 partners and associates we have more than 450 combined years of experience.

With our clear regulatory/quality focus, we are intimately familiar with the regulatory/quality issues you will need to address to succeed and can provide great insight on doing so easily and cost effectively.

We 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 600+ clients on CE Marking, CMDCAS, FDA, and Quality System Registrations.

Benefit from our 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 Online Consultant makes Quality Systems an investment in your future!