Online Inquiry
One-stop Solutions
At CD BioSciences, we provide an end-to-end, high-quality laboratory services ecosystem designed to bridge early translational research, clinical development, and eventual diagnostic commercialization. Powered by deep expertise in tissue histopathology, tumor molecular diagnostics, clinical specimen management, and digital pathology, we deliver robust, reliable, and standardized solutions to support biopharmaceutical developers, diagnostic companies, and clinical investigators globally.
Through our integrated platforms—encompassing tissue analytics, advanced spatial biology, liquid biopsy, and regulatory strategy—we help partners accelerate clinical trial timelines, stratify patient populations, de-risk biomarker validation, and successfully navigate complex regulatory pathways.
Core Solutions
Translational Research and Biomarker Development
Precision biomarker screening, functional validation, and correlation studies.
Clinical Trial Laboratory Services
Central laboratory operations, site support, and global specimen management.
Advanced Pathology and Tissue Analysis
Histology, multiplex IHC/IF, spatial biology, and custom target validation.
Companion Diagnostic Development
Co-development solutions from strategy to PMA regulatory submissions.
FISH and Hematologic Oncology Testing
Cytogenetic panels and flow cytometry for hematologic malignancies.
Molecular Diagnostics and Cancer Genetic Testing
Genomic profiling solutions for solid tissue and liquid biopsy ctDNA.
Digital Pathology & AI Services
We utilize integrated digital technologies, including scanning hardware, LIMS software, cloud infrastructure, and AI-driven image analysis to standardize slide evaluation, enable remote pathology collaboration, and deliver quantitative biomarker assessments.
Hardware & Software Ecosystem
- • High-resolution Whole Slide Imaging (WSI) scanning
- • Cloud Image Management System (IMS) & LIMS integration
- • Multi-site collaborative slide review & teleconsultation
- • Automated digitized FISH signal quantification
AI & Cloud Infrastructure
- • Deep-learning algorithms for cell segmentation
- • Spatial neighborhood mapping & quantitative scoring
- • Prognostic algorithm development & target discovery
- • HIPAA/CLIA-compliant cloud storage & security
Regulatory Consulting
End-to-end advisory services spanning IVD, medical devices, pharmaceuticals, and clinical trials.
| Sector | Regulatory & Strategic Capabilities |
|---|---|
| IVD Products | Molecular diagnostics, Companion Diagnostics (CDx), PCR assays, antigen/antibody kits, digital scanners, and laboratory validation documentation. |
| Medical Devices | Complete regulatory pathway strategy and dossier preparation for 510(k), PMA, Q-Submissions (Q-Sub), and EUA. |
| Pharmaceuticals | FDA engagement support: Pre-IND, End-of-Phase 2 (EOP2), Fast Track designation, IND, NDA, DMF, safety monitoring, and FDA meeting coordination. |
| Clinical Trials | Clinical study protocol design, trial site coordination, Laboratory Manual drafting, and global trial logistics management. |
Ready to Accelerate Your Clinical Pipeline?
Partner with our multidisciplinary experts to optimize your research strategy, streamline regulatory compliance, and shorten time-to-market.