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BioXcellerator Quality Management

The fundamentals of the BioXcellerator quality management system are based on the higest regulations and standards for cell therapy, safety.

BioXcellerator’s laboratory has been designed to comply with both regulatory cGMP standards for quality and meet internationally recognized ISO standards that cover safety, air quality, and processing infusions that contain human cells. 

The fundamentals of the BioXcellerator quality management system are based on the following regulations and standards for cell therapy, safety, and infrastructure conditions:

  • CAT Standards for the Obtention, Processing, Storage and Distribution of Blood Umbilical cord.
  • INVIMA (the institution that fulfills the role of the FDA in Colombia) Standards: Good Practices for Tissue Banks and Bone Marrow.
  • FACT-JACIE International standards for the collection, processing and administration of hematopoietic cell therapy products.
  • ISO 14644: 2016 Standard Air quality in controlled environments.
  • ISO 9001: 2015 Standard Quality Management Systems.
  • Colombian resolution 2378 of 2008 Adoption of Good Clinical Practices for Research with Medicines in Humans (specifically for clinical research projects).
  • ASS-RSA-GU045 Clinical Investigation Medicine and Supplies Guide INVIMA.
  • ISSCR International Society for Stem Cell Research.
  • GMP Spanish Agency of Medicines and Health Products.
  • Enabling Standards under Colombian Resolution 2003 of 2014.

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BioXcellerator Quality: BioXcellerator’s laboratory, has been designed to comply with both regulatory cGMP standards for quality and meet internationally recognized ISO standards that cover safety, air quality, and processing infusions that contain human cells. Disclaimer: Cell therapy offers no guarantees and is not promoted as a cure. This is similar to many other conventional medical treatments but it has scientific support. A review of the patient’s medical history is required to determine eligibility and approval for cell therapy. Any personal information provided is for internal and medical use with our medical providers only. BioXcellerator headquarters is located in Phoenix, Arizona. BioXcellerator Arizona is not a cell treatment facility or surgical center. Treatments are not conducted in our offices or in the U.S.  Since these advanced therapies are not yet approved by the FDA. Like all medical procedures, BioXcellerator procedures have a success and failure rate. Patient reviews and testimonials on this site should not be construed as a statement about the effectiveness of our treatments in general, they are individual perceptions that may or may not apply to everyone.

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