AssureImmune has set the highest standards for quality. Our quality control program is the heart of our business.
In 2010 the FDA issued a revised set of compliance guidelines for our industry called the “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”. These guidelines focus on the following areas for recommended compliance for how stem cells should be collected from individuals or humans:
- Reviewing communicable diseases
- Retain record information of donor testing
- Donor screening
- Requirements for donor testing
AssureImmune has received the full FDA registration. To download FDA registration approval click here »
We are currently working toward accreditation and/or certification with several leading American and International organizations that define quality standards in Cellular Therapy.
The accreditation process for these organization take months if not years of consistent performance in order to achieve this goal. AssureImmune has hired and consulted with scientists and technologists, who are highly experienced with the certification processes and blood banking regulations as well as cGMP Quality Systems. We have implemented a sophisticated information technology program and a rigorous Enterprise Resource Planning system to track and document process and quality activities to ensure compliance with world class operating procedures.