Why Use RegenALLIANCE
RegenAlliance is a Professional Educational and Group Purchasing Organization that is specifically designed to give each and every member an up-to-date, scientific education of Regenerative Therapeutic options, as well as, provide the ability to purchase Exosomes and Stem Cell products at the group wholesale pricing. As a solo physician or even a small group, there a many “barriers to entry” that affect your ability to develop a successful regenerative program within your practice. From an education perspective, your ability to keep up with the latest in Regenerative Therapeutics is difficult and time consuming. Financially, the ability to obtain the best pricing for purchasing your regenerative products is limited by your individual purchasing power and many times a requirement for sizable capital outlay. RegenAlliance was formed to overcome these two obstacles.
Screening and Pre-Screening
Our current partners, Direct Biologics and Utah Cord Bank, are known in the marketplace for their outstanding product purity, chain of custody and superior patient outcomes. Each of these facilities are currently applied and are prepared for the latest in FDA compliance registration processes. Tissue tracking and traceability is a requirement of the FDA. Every tissue that we deliver to our customers is traceable back to the tissue donor and our strict donor acceptance criteria.
Direct Biologics products are produced in a cGMP certified facility which oversees quality for every aspect of manufacturing, storage and distribution of our products. Direct Biologics donor screening includes the highly sensitive nucleic acid testing (NAT) for Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HIV, as well as, other required communicable diseases. Each product is tested for sterility, post-packaging, to meet USP requirements. The facilities are environmentally controlled and monitored for temperature and humidity with all freezers and storage equipment being monitored and maintained and our tissue is processed in an FDA inspected ISO:9001/13485 certified facility with Class 7 cleanrooms and ISO 5 GMP equipment. Part of our quality system includes document control, record control and process deviation control with a robust quarantine system that manages inventory only be released with approval by the Quality Engineering team.
Utah Cord Bank donors and donor tissues are rigorously screened for blood borne pathogens, heritable and non-heritable diseases or anomalies as well as environmental contaminants from medications to alcohol/drugs/tobacco & electronic vapor devices. Only healthy mothers who meet or exceed these thorough criteria are considered when collecting the birth waste tissue for use in all of UCB products. Finished products are tested a final time for contaminants as well as concentration and viability before being cleared for shipment.
RegenAlliance only partners with the most advanced scientific companies. We have spent countless hours screening companies that are “best-in-class” to provide our professionals with the confidence that they are providing the most effective regenerative therapeutic to their patients. RegenAlliance’s current partnerships include GX Sciences, Direct Biologics and Utah Cord Bank.
Utilizing our partnership with GX Sciences, RegenAlliance is delighted to provide our customers with the first of its’ kind genetically guided, scientifically objective regenerative therapeutic program. Our scientific team has made significant strides in our ability to scientifically validate, through Nutrigenomic testing, each patients’ individualized needs. Our process will determine the patients’ necessary pre-therapeutic nutritional preparation, as well as, objectively identify each patients’ most appropriate regenerative therapeutic process. The Nutrigenomic testing of the individual patient is able to provide our professionals with an objective methodology that is not found in other physician alliances.
Community of Data
By creating a community of professionals, RegenAlliance is able to gain valuable insight from out members. Scientifically, the objectivity of genetic testing allows for a standardization of therapeutic modalities that should lend credibility to the RegenAlliance methodology. RegenAlliance also possesses the ability to evaluate your patient’s data and provide comparison data from other members in the alliance.
Currently, RegenAlliance is in the process of creating an Institutional Review Board (IRB) that will allow members to participate in a company-wide process that affords some individual protection from non-FDA approved therapeutic treatments.