In May of 2005, the FDA began enforcing a comprehensive set of new regulations designed to improve the safety of human cellular and tissue based products (HCT/P’s). This new set of regulations, put forth in 21 CFR 1271, is arguably one of the more important events in regulated industry in recent memory. The new regulation not only expands the regulatory requirements on tissue products previously regulated under 21 CFR 1270, but also brings a variety of tissue products under regulation which were previously unregulated by FDA. While distinctly crafted around control of communicable diseases and disease agents, the new regulation dramatically increases the level of control and extent of quality systems needed by this industry for ongoing compliance.

Reglera has developed many industry specific services designed to help the reproductive segment of the tissue banking industry comply with the various regulatory requirements that now affect their business operations. These services are designed to provide a high level of regulatory compliance while allowing clinical staff to continue to focus on reproductive medicine and their patients.

Reglera has many years of experience in the Reproductive Tissue Banking industry. Our expertise comes not only from setting up compliant regulatory and quality systems but also from practical business experience.

If your organization can benefit from a regulatory partner that understands the reproductive tissue industry complexities as well as tissue specific regulations, do not hesitate to contact us for further discussion.