Reproductive Medicine & Fertility
One of the core passions of Covita Health Partners is supporting the reproductive medicine and fertility sectors. Fertility doctors and nurses dedicate their days to helping people grow their families who are having difficulty doing so. They also spend years going to school and conferences to learn the best practices and modern medical innovations in order to do just that. CHP believes that doctors and nurses should spend their time fulfilling their passions: helping people become parents or grow their family. Let us fulfill our passion – regulatory and quality – on your behalf. It’s the small part we can play to see their patient’s dreams for a family come true.
Oocytes and semen are regulated by the US FDA as human cell, tissue, and cellular and tissue-based products or “HCT/Ps”. Reproductive and fertility clinics and other facilities which collect oocytes and semen from donors, screen and/or test donors, or process, store, label, package or distribute oocytes and semen, must comply with the FDA’s requirements for registration and listing, donor eligibility and good tissue practices. It can be difficult to stay current with ever changing FDA policy and guidance, and we’re here to guide you through the requirements and provide support throughout the growth of your business.
In addition to FDA requirements, states continue to implement laws regulating the fertility industry. Not only can CHP help you comply federal requirements, but we can ensure that your business is staying in compliance with applicable state requirements as well.
Examples of projects clinics and agencies consistently engage us for are:
Donor Eligibility Support
Internal Audit
FDA Audit Support
Exemption Requests
SOP Implementation
483 Response & Remediation
Reproductive Medicine is also more than oocytes, semen and embryos – it is also diagnostic tests designed to detect a biomarker for endometriosis, devices that analyze saliva or urine to help track ovulation, and artificial intelligence algorithms to assess the quality of follicles, oocytes and embryos. Regardless of the form reproductive medicine takes, our team is here to help you see it reach the patients who need it on budget, on time, and in compliance.