Medivdpharma (MIP)
Our Core Capabilities
Biomarker Identification & Selection
→ Discover and validate biomarkers predicting drug response.
Assay Development & Validation
→ Design and validate robust, reliable diagnostic assays.
Clinical Development & Validation
→ Execute global, multi-site studies in sync with therapeutic trials (Phases I–III).
Regulatory Strategy & Submissions
→ Expert guidance across FDA, IVDR, PMDA, and NMPA pathways.
Quality Management Systems (QMS)
→ Compliance with ISO 13485, GCLP, CLIA, and CAP standards.
Clinical Trial Support
→ Manage CDx use as a Clinical Trial Assay (CTA) — from training to monitoring.
Manufacturing & Commercialization
→ Scale up CDx kit production and navigate pricing, reimbursement, and market access.
Post-Market Surveillance
→ Ensure long-term success with continuous monitoring and label alignment.
Bioinformatics & Biostatistics
→ Turn data into actionable insights that power precision decisions.
- Complete CDx lifecycle expertise
- Streamlined regulatory and development pathways
- Proven global project execution
- Faster time-to-market for both drug and diagnostic
