From global IVD regulatory, IVDR consulting to clinical studies and post-market support, we have what you need, when you need it.

 

NAMSA can work with your team in several capacities and on a global scale. Some clients choose to outsource all regulatory, quality, and clinical research initiatives, while others partner with us on portions of their IVD regulatory or clinical study processes. No matter the program, NAMSA is the most flexible CRO partner in the industry, and we pride ourselves on delivering only high-quality results by leveraging our collective global expertise.

 

On a daily basis, NAMSA partners with global regulatory bodies to understand expectations and new regulations. We are intimately familiar with how to navigate IVD regulatory requirements throughout every geography in the world.

 

It is a full-time job keeping up with regulations within each global market and therapeutic area that pertain to your business such as IVDR and being able to manage multiple clinical trials in multiple geographies. NAMSA has a local presence in every key medical device geography around the world to support  IVD regulatory strategy requirements as well as clinical trials and quality management systems.

 

We assist our clients with clinical trials worldwide from the U.S. to APAC and  Europe to Latin America.   We expertly manage multiple studies in multiple countries simultaneously.

 

Unlike some CROs, NAMSA’s IVD team has expertise with hundreds of successful regulatory submissions for China, Japan, Europe, North America and other parts of the world so we can manage all of your submissions. This makes it easier on you so you don’t have to oversee multiple vendors in multiple countries. Since we work globally and have near daily interactions with global regulatory authorities, we understand current regulations, can anticipate risks, and routinely develop strategies to overcome risks. We provide IVD regulatory strategies in each global market and are able to assist with changes like IVDR. Our teams prepare product applications, submit reports and collaborate with you to finalize your submission dossier and technical file materials.

 

We realize that IVD clinical trials are vastly different from medical device and pharmaceutical trials. We have a broad network of trusted research sites in every geography around the world, as well as labs with whom we have worked in the past. We are continually focused on building relationships with new sites, all to serve our clients’ research needs better.
In comparison to medical devices and pharmaceuticals, the IVD product development lifecycle is different, the site requirements are different, data collection varies and there are unique challenges that manufacturers must mitigate. NAMSA works with clients every day to overcome these challenges, and applies lessons learned to help clients accelerate products through the clinical trial phase.

 

NAMSA is flexible and can work with you for all regulatory consulting, quality system and clinical research needs, a la carte or as a turnkey solution.

 

Services Provided by NAMSA:

Regulatory and Medical Writing

  • Global Strategy & Submission
  • Investigational Device Exemption (IDE)
  • 510(k)
  • Premarket Approval (PMA)
  • CE Mark
  • Submissions
    • China FDA (now NMPA)
    • Health Canada
    • EU Notified Bodies
    • Japan’s PMDA
    • US FDA
  • Submissions for Companion Diagnostics
  • Device Master File
  • Design Dossier / Technical File
  • In Vitro Diagnostic Regulations (IVDR)
  • Performance Evaluation Report Creation and Updates (PER)

 

Clinical Research, Biostatistics and Data Management

  • Study Types: Feasibility, Pivotal, Specimen Collection, Human Factors, Reproducibility, Limit of Detection, Clinical Performance, Formative & Summative Usability
  • Post-Market Surveillance (PMS) / Post-Market Performance Follow-Up
  • Study Design & Implementation
  • Site Selection/  Qualification
  • Biostatistics/  Data Analysis
  • Database / Data Management
  • Monitoring
  • Clinical Audits & Bioresearch Monitoring (BIMO) Audit Support
  • Instructions for Use

 

Quality Systems

  • Development Support
  • Gap Analysis
  • ISO 13485:2016 Transition
  • IVDR Transition
  • Quality Audits

 

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 via our contact form.