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The company is a wholly owned subsidiary of Enscicon Corporation, a technical services and staffing company, serving a variety of technical industries since 1994.
The business model developed for Reglera was the final result of more than eight years of work with customers in the Medical Device / Bioscience Industry and is intended to directly address the major drawbacks of the most prevalent consulting model used in this industry segment while providing clients with highly valued regulatory expertise. As a result of the similarities between 21 CFR 1271 (Good Tissue Practices), and 21 CFR 820 (Good Manufacturing Practices), the tissue industry was an easy transition for Reglera’s quality and regulatory associates. Through our work with numerous tissue manufacturing organizations, our relationship with FDA’s Center for Biologics (CBER), and our involvement with various industry trade associations, we have developed a comprehensive understanding of the unique nature and subtleties of 21 CFR 1271.
Our consulting services have been designed to address any areas involving regulatory or quality requirements as dictated by FDA regulations and international standards, including 21 CFR 820, 21 CFR 1271, 21 CFR 11, and ISO 13485:2003. Some of the areas we provide consulting expertise include: Quality Systems Assessments Compliance Remediation Submissions Quality System Development Validation Our work is always guaranteed to meet the expectations of FDA or we will fix it at no charge. When possible, we quote our consulting projects on a fixed bid basis to ensure you know the cost prior to initiation of any work. Whether you need an expert to review your regulatory strategy, advise you on your relationship with FDA or provide guidance based on our experience, Reglera can provide you with the right resource.
Consulting Services Quality System Assessment Setting up and maintaining an effective quality system is essential in order to ensure that products are safe and effective for their intended use.
… More detail Compliance Remediation If any inspection results in a compliance action from the FDA, or requires corrective action, our experience in compliance remediation can help you … More detail Submissions When it is time to get your product to market, there are a number of options available.
We work closely with clients to develop a submission strate… More detail Quality System Development The foundation of any successful organization is a system that ensures consistency, quality and repeatability. Reglera understands that all busines… More detail Services Services Consulting Top Copyright 2012 Reglera.
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Source: (human tissue regulation) http://www.reglera.com/services/services/consulting
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