BIOMARKER REGULATORY QUALIFICATION
We help our clients to optimize each step of their biomarker research and development programs, from concept to regulatory qualification for all international markets.
Our team has significant experience in the regulatory qualification of biomarker-based panels and in vitro diagnostics (IVD) tools in Europe (development and submission for CE marked kits) and in the US (IVD and LTD kits) according to EMA and FDA guidelines.
Use our expertise in analytics, regulatory strategy, and in biospecimens solutions for comprehensive support across your research needs:
- Design of biomarker program and analytical development
- Planning and study design
- Development of Standard Operating Procedures (SOPs)
- Regulatory support: preparing dossiers and opinion meeting
- Biomarker regulatory qualification for IVD development
Contact us now to get further details about Firalis Consultancy Service and to discuss your projects.