Quality

Since 2020, Novo Laboratories, LLC has been registered with the US Food and Drug Administration Center for Drug Evaluation and Research (CDER) as an Analytical Laboratory and with the Center for Biologics Evaluation and Research (CBER) as a Human Cell and Tissue Establishment (FEI 3016906323). Novo Lab’s quality management system complies with FDA regulations, ISO standards and follows Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).

Quality Policy

Novo Lab is committed to complying with relevant laws, regulations and internal requirements, meeting or exceeding customer expectations and maintaining a quality program that promotes product safety and efficacy.

We pledge to:

  • Uphold the highest level of quality in every aspect of our work, from initial concept through to final delivery, ensuring that our services and products consistently meet the expectations of our clients and regulatory authorities.

  • Maintain a rigorous Quality Management System (QMS) that emphasizes risk management, process control, and continuous improvement, all while fostering innovation in our services and products.

  • Ensure all team members are not only versed in but also committed to our quality objectives and are equipped with the training and resources necessary to achieve these goals.

  • Engage in proactive and transparent communication with our clients and stakeholders, ensuring that all feedback is utilized to improve our processes and outputs.

  • Conduct regular audits, both internal and external, to systematically measure, analyze, and enhance our quality standards and performance.

  • Stay abreast of and integrate the latest FDA guidelines, industry best practices, and advancements in biologics and regenerative medicine, ensuring our clients benefit from the most current and compliant approaches.

  • Our dedication to quality is unwavering, as we understand that the services and products, we provide play a critical role in advancing healthcare and improving patient outcomes. At Novo Lab, we don't just comply with standards—we aim to set them.