When you work with NAMSA, you have access to experts who have managed numerous studies in your therapeutic area and geographic location – from working with the FDA, managing a CE marking or seeking approval via China’s FDA (NMPA), we’ve got you covered.  

 

The breadth and depth of knowledge and application experience that the NAMSA team possesses is enough to power any IVD program. From infectious disease devices, cardiac markers, diabetes care and point-of-care diagnostics, we are the IVD CRO leader. We know the market intimately, we understand the sites that can best conduct your IVD trial, and we are familiar with your competition. Most critically, we understand the importance of getting you to market first. Our teams use their expertise to help you navigate unique regulatory and clinical requirements for the FDA, CE marking under IVDD or IVDR, CFDA (now NMPA) and other submissions throughout the world.

 

 Clinical trial sample collection, processing and storage can be a logistical difficulty, often overlooked by other CROs. NAMSA’s team will ensure nothing is left off your list.

 

NAMSA’s expertise goes beyond specific therapeutic areas. We understand what you will face and make you aware of these challenges while guiding you through the requirements you never even anticipated. This is imperative to product launch success. This expertise has kept us in business for over 50 years and has allowed us to serve and keep clients happy every day. Whether you are working on an IVD FDA submission, an IVD CE marking, a submission and approval in China or any other global submission, we are here to support you.

NAMSA’s most requested IVD therapeutic expertise includes:

  • Clinical chemistry
  • Immunodiagnostics
  • Infectious disease
  • Hematology
  • Cardiology
  • Diabetes
  • Endocrinology
  • Microbiology
  • Companion diagnostics
  • Genetic sequencing
  • Women’s health
  • Regenerative medicine

For a complete list of IVD experience, click here

 

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