Ontario – Toronto GTA – North York
Corporation
www.horizonphoenix.biz
Ontario
Toronto GTA
North York
Corporation
active
Quality and regulatory consulting services for the Medical device, biotechnology and pharmaceutical industries. Canadian, USFDA, CE Marking and more - virtual worldwide unimpeded market access. Product experience spans high volume disposables, drug/device combinations, in vitro diagnostics and long term implantables. Authorized European Representation and US Agent Services. Faster, easier market access with full regulatory compliance.
Country of Ownership: Canada
Year Established: 1992
Exporting: Yes
Primary Industry (NAICS): 541990 - All Other Professional, Scientific and Technical Services
Primary Business Activity: Services
Services:
Market access approvals, regulatory affairs/quality management systems
Technology:
450+ years combined experience in medical device, biotechnology and pharmaceutical industry - product testing, clinical trials, regulatory and quality management systems.
Sector:
Distribution of Employees
Worldwide reach through six operating locations (Canada, the US, Ireland, New Zealand, China and the UK).
Unique Applications: Drug/device combinations and everything from low cost high volume injected molded product to artificial organs.
Key / Major Clients: Multi-billion dollar multi-nationals to mom and pop manufacturers financing operations on a second mortgage. Three person niche companies to the United Nations.
Success Stories: 510K, CE Mark and Canadian medical device licensing in less than 90 days. Multi-site clinical trials on time and under budget. Resolve outstanding 483s, major non-conformances and warning letters.
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Profile ID: LFCA-COD-O-32052