Worldwide Regulatory Services for Medical Industry
By Biotechdaily staff writers
Posted on 20 Sep 2002
A consulting company provides comprehensive worldwide regulatory services to the medical industry.Posted on 20 Sep 2002
The company, Regulatory Insight, Inc. (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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Regulatory Insight, Inc.
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