Regulatory Support Tablet Image Regulatory Support Mobile Image
Mobile Gradient

Regulatory Support

Regulatory Support Tablet Image Regulatory Support Mobile Image
Mobile Gradient

Regulatory Support

 

Almac Diagnostic Services regulatory affairs team has extensive experience in engaging with global regulatory authorities throughout the IVD and companion diagnostic (CDx) lifecycle, drawing on an in-depth knowledge of molecular diagnostic product development. 

We provide invaluable support to our clients from the investigational clinical trial phase through to the post-market phase, resulting in successful regulatory submissions and ultimately a fast and efficient path to market.

Stand-alone Consultancy or Product Development Service:

Our regulatory services can be provided either as a stand-alone consultancy service or as part of an over-arching product development service. Engage with us early to determine how we can best support your needs.

Our full range of regulatory support solutions include:

  • Global regulatory strategies for CDx development
  • IVD/CDx Q-submissions (pre-submissions, study risk determinations, informational meetings)
  • FDA IDE & PMA submissions
  • IVDR compliant technical documentation
  • EU Notified Body engagement 
  • EU device & performance evaluation registration/application
  • Device classification assistance
  • Performance evaluation planning & reporting (scientific, analytical and clinical, including bridging studies)
  • 3rd party investigator/site selection, initiation, monitoring and close-out (inclusive of sites within China)
  • Benefit-risk analysis
  • Change control and associated risk analysis
  • Regulatory submissions
  • Regulatory agency liaison (including supporting our client’s FDA CDER/IND engagements)
  • Medical device reporting
  • Post-market surveillance & support (e.g. PMA supplements)

Almac provide Regulatory Support Services to support the entire CDx lifecycle

This website uses cookies. By continuing to browse the site, you are agreeing to our use of cookies