About the Horizon Phoenix Group LLC
HORIZON PHOENIX is a partnership comprised of thirty-seven professionals who combined have more than 450 years experience in product testing, regulatory processes, quality management systems and audits/assessments. With six operating locations we are well placed to provide you with timely and cost effective professional services.
Our clients range from a five-person niche market manufacturer, to multi-national conglomerates and non-government organizations such as the United Nations. In addition to regulatory affairs and quality assurance, we can offer practical experience in every facet of your operations including research and development, design transfer, upscaling production, streamlining operations and enhancing your customer loyalty.
Hallmarks of Horizon Phoenix professional services:
- You are treated with respect – we understand your time and resources are not infinite.
- Maintaining the focus on your operations – first and foremost.
- Personal, responsive services – no fill in the blanks, no cookie cutter approaches.
- Your needs, expectations, timelines and budget constraints come first.
Not only compliance but cost effective compliance. - Market access and regulatory are integrated into one easy-to-use process.
- Nothing is implemented that does not add value to your operations.
- You hire a team of experts, not a single consultant.
- We teach your staff so that the skills and expertise reside in house.
Nothing we do is about survival! Our experts specialize in growth, prosperity and market leadership.
If you want to be on the cutting edge, saving time and money but most importantly staying off the chopping block, Ask Us How!...
Horizon Phoenix Group Capabilities and Experience
Our partners and associates have more than 300 combined years of experience in medical devices, biotechnologies and pharmaceuticals. We have successfully completed projects for every size company from niche market to multi-national conglomerates and have worked on every continent except Antarctica! Our partners and associates have helped develop national, regional and international standards and played key roles in the development and implementation of regulations and compliance processes.
We use our breadth of experience to help you navigate the quality management/regulatory compliance maze so that you may quickly and efficiently achieve your goals.
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HORIZON PHOENIX REGULATORY COMPLIANCE SERVICES |
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USFDA |
USFDA Market Access Submissions |
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QSR cGMP cGLP Design (pre and post R&D) Pre-QSIT assessment 483 and Warning Letter Resolution Process Validation Risk Management HAACP Software Validations Clinical Evaluations |
510k PMA IDE HDE IND ANDA NDA BLA |
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Preclinical Testing and Evaluation |
CE Marking |
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Design, competitive bidding and management of: Toxicology Biocompatibility Device Comparative Studies Literature Studies Animal Testing EMC/EMI testing Electrical Safety Testing Sterilization method selection and validation |
Self Declaration Harmonized Standards STED File Development Design (pre and post R&D) Medical Device Active implantable In Vitro Diagnostic Risk Assessment Risk Management Drug/Device Combinations Post Market Surveillance Vigilance Resolution of Notified Body non-conformances cGMP cGLP Software Validations Clinical Evaluations Usability Evaluations |
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Clinical Testing and Evaluation |
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Design, competitive bidding and management of: Human clinical trials |
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Quality Management Systems |
Canadian Regulatory Compliance |
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ISO 13485 cGMP cGLP FDA QSR Design and implementation Fine Tuning and problem solving Internal Audits Management Review |
CAN/CSA ISO 13485 implementation Safety and Effectiveness CMDR compliance Medical Device License submissions Establishment Registration Pre-inspection evaluation |
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Mentoring |
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All aspects of Quality and Regulatory Affairs Training Personal Coaching Maternity Leave or Long Term Disability coverage |
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HORIZON PHOENIX PRODUCT EXPERIENCE |
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In Vitro Diagnostics |
Medical Devices |
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Blood Grouping Reagents Antigen and antibody reagents for rare phenotypes Blood and Tissues for transplantation Sole Analyte Drugs of abuse test kits Cancer detection test kits Blood Glucose Monitors Skin Allergy Test Kits HIV Test Kits
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Injection molded parts Steel fabrication Long term cardiac implantables Catheters Indwelling peritoneal dialysis catheters Intraocular lenses Ventricular assist devices Diagnostic Imaging Equipment Electromedical equipment Digital Radiography (including mammography) Dressings and barrier products Surgical Gloves Contact lenses (plain) Contact lenses (with antimicrobial features) Oxygen concentrators Dental instruments and sealants Phototherapy Wheelchairs Sleep Apnea Monitors |
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Personal Protective Equipment |
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Radiology gowns and aprons Masks and gloves
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Laboratory Services |
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cGMP cGLP Quality Management Systems Water Systems validation Microbiology Chemistry Urology Histopathology Serology Human leukocyte antigen Reagents, standards and solutions Blood and Tissues for transplantation IQ OQ PQ validation |
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In order to best serve you, we have offices in Canada, the United States, Ireland, the United Kingdom and China.
Simply call 289-389-5454 to speak with an experienced Horizon Phoenix consultant who will help put you back on the cutting edge!