About NQ8
At NQ8, we assist clinical labs and healthcare innovators with navigating the transition from laboratory-developed tests (LDTs) to in vitro diagnostics (IVDs). 𧬠Our goal is to bridge the gap between cutting-edge laboratory innovation and strict regulatory compliance, allowing labs to stay at the forefront of diagnostic advancements while maintaining high standards of patient care. π₯ We specialize in guiding laboratories through the complex regulatory landscape by offering tailored solutions that streamline the entire process, from initial feasibility studies to full regulatory submissions. π Our expertise in FDA and international IVD regulations enables labs to confidently transition their LDTs into fully compliant, market-ready IVD products, improving diagnostic quality, patient outcomes, and operational efficiency. π π‘ Our key services include: β Regulatory compliance and transition support π οΈ Custom digital tools for seamless process management, validation, and compliance π Global IVD standardization to meet international regulations for distribution π IVD development and certification preparation π» Virtual regulatory guidance tailored to your specific needs Partnering with NQ8 allows labs to gain a strategic ally committed to driving innovation, enhancing diagnostic quality, and ensuring excellence in regulatory compliance. π Together, we can accelerate your lab's success in the rapidly evolving diagnostic landscape. β‘
- Employees
- 1 to 10
- Headquarters
- United States
Leadership
The top of NQ8's org chart, with how many people report into each leader.
Antonio T.
Chief Executive Officer
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