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)