Uniquely IVD.

 

More than just a CRO.

 

Built for the unique needs of IVD manufacturers.

 

NAMSA is a leading global contract research organization (CRO), and the world’s only Medical Research Organization (MRO),that assists in vitro diagnostic (IVD) and companion diagnostic manufacturers to translate great ideas into great medical products.

 

NAMSA understands IVD product development and our specialized IVD team partners with you throughout every step of the process.

 

NAMSA has built a stand-alone business unit focused on the unique needs of IVD product development. Our history of supporting numerous IVD and medical device manufacturers has provided great knowledge and expertise to our quality, regulatory and clinical research teams.  As medical technology industries evolve and start to grow in different ways, you should expect the same from your IVD CRO partner.

 

The regulatory, quality system and clinical research expertise within our IVD team is second to none. We utilize only the most specialized IVD experts familiar with the market and who are experienced in guiding sponsors on the correct path so they can stay ahead of the trends. We work with you to develop the best-fit regulatory strategy that gets you to market faster – before the competition – and supports your future growth objectives. Whatever your goals may be, from building a solid quality system foundation to post-market launch support, we have you covered.

 

We offer comprehensive IVD CRO services and have the specific expertise in-house that enables you to launch your product and to successfully stay on the market. Our regulatory specialists support:

  • product classification determination
  • regulatory pathway and strategy
  • regulatory submissions
  • technical file builds
  • communication with Competent Authorities, Notified Bodies and other regulatory bodies around the world

NAMSA is also at the forefront of the new EU in vitro diagnostic regulation (IVDR) and our quality system and regulatory specialists, combined with our Performance Evaluation Report (PER) writers, can help you ensure IVDR compliance by May 2022.

 

Each day, over 500 clients in countries around the world trust NAMSA to manage their clinical research, regulatory and quality needs. 

 

Throughout the clinical research process, our clinical trial managers are expert at supporting your global study management, site selection/ management and monitoring requirements.  NAMSA has highly-skilled and industry-trained biostatisticians on staff that elegantly design your clinical studies and analyze the critical data necessary to achieve regulatory and marketing objectives. Lastly, our data managers understand the nuances of collecting instrument and sample/subject data within clinical trials and can effectively manage the most critical asset – your data – as you oversee   your clinical trial outcomes.

 

NAMSA  employs the industry’s premier quality systems experts to effectively design quality systems and to ensure your compliance with ISO 13485:2016, U.S. FDA CFR 21 part 820. These experts are also skilled at transitioning IVD manufacturers from IVDD to IVDR in the most effective, timely manner possible. We also allow global IVD manufacturers to successfully stay on market.  If you are unsure where to get started, NAMSA offers gap assessments to help identify needs and suggested strategies for compliance and  streamlined operations.

 

NAMSA offers product development lifecycle support for regulatory, clinical and quality services in several therapeutic areas.

 

Are NAMSA’s services a good fit for your needs? Contact a NAMSA representative +1-866-666-9455 (+1-419-666-9455 outside the U.S.) or through our contact form.