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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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