Regulatory Support

 
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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

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