Join the competitive marketplace and become FDA certified
What is FDA Consulting?
Sunray Fertility provides a variety of FDA regulatory services to doctors and fertility clinics around the world to ensure they are FDA compliant for the United States. We offer a seamless approach to help your organization navigate the regulatory intricacies associated with manufacturing, processing, storage, labeling, packaging and distribution of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P), as well as facility and product registrations and listings.
Why does your clinic need to be FDA certified?
Any foreign establishment engaged in manufacture (i.e. recovery, distribution) of HCT/Ps for import to the U.S.A must register with the FDA, submit and list each human tissue product type manufactured, and comply with all applicable FDA policies and regulations, unless exempted by the FDA.
What are the benefits of being FDA certified if you are not in the U.S.A?
Once you become FDA certified, your clinic can ship any gametes (eggs, embryos, sperm) to the U.S.A to be used by any clinic or doctor in the U.S.A. As travel can be expensive, this option allows overseas clinics to join the competitive U.S. industry and offer their services at a much lower cost. Our team of fertility regulatory experts are ready to provide assistance that will help your organization succeed in this highly complex and very competitive regulatory environment.