CDx regulatory requirements
Companion Diagnostics FDA and IVDR
Companion Diagnostics FDA and Companion Diagnostics IVDR (CDx), personalized medicine, and clinical trials assay (CTA) require specialized regulatory knowledge and practical experience. This sector is experiencing a multitude of changes as the technology evolves at the same time as the regulations are in flux; this includes:
- Clinical Trial Regulation (CTR) in Europe
- IVD Regulation in Europe
- Changes to the classification of some CDx devices in the US
- Transition of Lab Developed Test (LDT) in the US to FDA-cleared services as 510(k) or PMA.
All stakeholders are learning by doing. Our IVD experts have extensive experience working with both pharma and diagnostic partners in this sector, supporting both parties to help them work efficiently together. Not all assays used in clinical trials will become commercial IVD assays, and the Qserve team has experience in navigating this tricky area in both Europe and the US.
The team provides regulatory consultancy support across the entire IVD product development lifecycle, from developing a clear strategy to supporting clinical trial assays or IVD clinical performance studies. We can support the preparation of technical files for Europe or 510(k) or PMA regulatory submissions to bring Companion Diagnostics to both the US FDA and European markets.
Do you need help with your Companion Diagnostics FDA or Companion Diagnostics IVDR?
Qserve is your trusted partner to setup the regulatory strategy
and fulfill the Companion Diagnostic Process.
Contact us
Companion Diagnostic Process
Precision Medicine Clinical Trials & Diagnostic Development
As precision medicine diagnostics require the development of both drug and device, Qserve’s services are relevant to both the Pharma/Biotech and Diagnostic stakeholders. We have experience working with both pharma and diagnostic partners, large and small, to help fit together the regulatory paths of both sectors to operate as efficiently as possible.
Qserve supports the companion diagnostic process:
- Diagnostic Strategy
- Diagnostic Partner Selection
- Diagnostic Product Development
- Clinical Performance Study | Investigational Device Exemption Submissions
- Clinical Performance Study Conduct
- Premarket Applications | Conformity Assessment Submission
Qserve IVD CDx consultancy services
Companion Diagnostic Services
- Strategic regulatory advice
- Study design
- Medical and technical writing
- Technical documentation review
- QMS support
- Legal representative
- Authorized representation
- On-site or remote training
- Ad-hoc support
Clinical Trial Assay (CTA)
Used in early-phase Pharma studies
- Advise on Clinical Trial Assays (CTA), clinical performance study authorization requirements, ethics committee approval, and the process per country
- Advise or draft clinical performance study protocol
- Analytical study designs, protocols, reports
- Bridging study design