Explore our Broad Range of BioPharma Services and Capabilities
As a Contract Diagnostic Organization (diagnostic-focused CRO), we’re a ‘one-stop shop’ for biopharmaceutical companies seeking diagnostic development, Clinical Program Support, Regulatory Filings, and GMP manufacturing services. ResearchDx offers a comprehensive range of biopharma services to build, validate, and deliver a regulatory-approved diagnostic assay through the efficiency of outsourcing to a single partner.
Your project is unique—and unique is our specialty. With all diagnostic services housed under the same roof, you will have but one point of contact for your project rather than the many contacts associated with multi-vendor contracts. We manage and ensure every project is designed and implemented with your goals and schedules. And, should your project timelines or priorities need to shift — as your single IVD diagnostics resource, we adapt to meet your needs. We maintain proficiency, competency, and expertise in all areas of diagnostics.
Research & Development
- Biomarker discovery and validation (molecular, protein, other)
- Platform agnostic, your platform or ours
- Assay/kit development and validation
- Platform evaluation and automation
- Studies to establish a biological baseline
- Broad, multi-platform technology capability (no bias)
- LDT/custom development/clinical validation
- NGS platforms—Illumina, Thermo Fisher, etc.
- PCR platforms—Qiagen, Thermo Fisher, BioRad, etc.
Clinical Trials and Consulting
- Complete clinical trial services, program management, and support
- Clinical trial strategic consulting
- Reference trial testing services
- Clinical primary site testing
- Analytical and clinical testing
- Complete data management program support
Regulatory and Quality
- Regulatory strategy (e.g., FDA)
- Regulatory agency interactions
- IVD PRE-IDE, PMA, and 510(k) filings
- International regulatory filings
- Compliance auditing and consulting
- Compliant labeling
- Software documentation
- Third-party review by Accredited Persons (AP)
Laboratory Services
- Premier high-complexity molecular specialty testing resource
- Fully credentialed clinical laboratory (CLIA, CAP, multi-state licensure). Supporting clinical trial assays (CTA), laboratory-developed tests (LDT), and assays validated under good laboratory practice (GLP)
- Broad, multi-platform and technology capability (no bias)
- Preclinical, clinical trial and GLP testing services
Manufacturing Services
- ISO 13485 GMP manufacturing compliance
- Custom reagents, assays, or final kits for research, clinical, final product
- Molecular/non-molecular IVD development
- OEM reagents, kit components, or assays
- Certificates of Analysis (COA)
- Sample collection kits
Regulatory Support
In addition to managing your 510(k) or PMA development, we also offer the following services:
- Regulatory Strategy and Pathway Determination
- Facilitation of activities with domestic and international regulatory authorities
- Pre-submissions, 513(g) IVD PRE-IDE, PMA, and 510(k) filings
- Technical File and Design Dossier preparation and maintenance
- Product Labeling
- Facility Registration
- Warning Letter Mitigation
- Compliance auditing and consulting
- Software documentation
- Third-party review by Accredited Persons (AP)
- On-site consulting for product development projects
Dedicated Project Resources
- Dedicated project management
- Scientific and medical expertise in all areas of IVD diagnostics
- Premier credentialed high-complexity CLIA laboratory
Please browse our website to obtain more information on your specific needs!