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Ad Title: Regulatory &Quality Systems Solutions

Brief Description: Our medical device and human tissue 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: • Regulatory Consulting/Strategy •    Quality Systems Development •    Compliance Remediation • Submissions •    Validations (facility,process,product,software) •    Audits (internal, supplier quality audits, qualification of supplier lists) •    Complaint Handling •    Quality Systems Assessments

Expanded Description: We have about 50 employees in our offices located in Lakewood, CO, and an additional national network of ~150 consultants across the country. Our approach is unique. We have several proven areas of expertise that allow us to seamlessly work with a client whether they have regulatory, quality or other outsourced service needs as defined by either Medical Device or Human Cellular Tissue FDA or ISO guidance. Today’s landscape requires working with a company that has a solid infrastructure, and not just a 1-2 person consulting team. We have active clients in over 30 states and several countries.

Mr. Brian Tucker
Director of Business Development
Reglera, LLC
[email protected]

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