Quality Commitment
Quality Statement
OUR PROMISE
Vivere Biologics is dedicated to adhering to all relevant laws, regulations, and internal standards, ensuring we consistently meet or surpass customer expectations. At Vivere Biologics, we don't just meet standards—we strive to set new ones.
What makes our Product so Great
Our Certifications and Compliance
- FDA Registered: Certified by the FDA's Center for Drug Evaluation and Research (CDER) as an Analytical Laboratory.
- Human Cell & Tissue Establishment: Recognized by the FDA's Center for Biological Evaluation and Research (CBER) for our Human Cell and Tissue operations.
- ISO-Certified Cleanrooms: Our facilities include ISO Class 5, ISO Class 7, and ISO Class 8 cleanrooms, ensuring a sterile and controlled environment.
- Quality Management Excellence: Our quality management system adheres to FDA regulations, ISO standards, and incorporates Current Good Manufacturing Practices (cGMP), Current Good Tissue Practices (cGTP), and Good Laboratory Practices (GLP).
- Sterility Assurance: Every product undergoes rigorous sterility testing through an independent FDA-registered and CLIA-certified laboratory.