Worldwide Regulatory Services for Medical Industry

(Littleton, CO, USA), says its clients benefit from its years of experience and established relationships with various regulatory bodies. The company promotes a collaborative approach to expediting all regulatory processes in an effort to save both time and expense.

The key services offered by the company include the following: US, Canadian, and European regulatory submissions; US agent representative for foreign companies; quality system development and review as per FDA's Code of Federal Regulations, the European Medical Devices Directive, and ISO-9000; clinical study design, monitoring, and analysis; and product recall/safety alert responses and corrective action plans.

The company also offers management or assistance with FDA or ISO inspections in preparation for import/export issues and market research to evaluate product design, market viability, and customer identification.




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