Reglera, LLC is a leading organization specializing in quality and regulatory consulting and process outsourcing. Reglera focuses on two primary industries: medical devices and human cellular and tissue products. Since 1994, Reglera has been helping tissue and medical device companies navigate the regulatory maze through its expertise and understanding of regulatory and quality systems requirements.
Reglera and ReproTech have worked together to develop services and products which can help bring reproductive clinics into compliance quickly. Clinics which use our Electronic Donor Eligibility System (DES), benefit from having a web-based application to support donor screening, review, examination, and testing, but also benefit from having Reglera regulatory expertise at their fingertips.
This system is specifically designed to provide IVF facilities with the ability to fully automate the donor eligibility process in a way that is not only compliant with FDA 21 CFR 1271, but to speed up eligibility determination, increase efficiency, and save money. Built to support geographical organizations via the DES web portal, the status of donors can be easily monitored from any web enabled computer, and the system supports remote electronics approvals compliant with 21 CFR Part 11.
The Donor Eligibility System is more than a website. It is a proven process, which incorporates a systematic approach to help aid donor organizations in managing their donor eligibility process including work flow and all required records. For more information about the Reglera and Reprotech Donor Eligibility System please contact Reglera at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
Reglera, LLC:
11925 W. I-70 Frontage Rd. North
Suite 900
Toll: 800-341-4255
Local: 303-832-8200