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