Consulting
The ResearchDx philosophy is to provide clear, accurate guidance to the Biopharmaceutical, Biotechnology, Clinical Diagnostics and Clinical Laboratory industries.
Biopharmaceutical and Diagnostics Consulting:
Trust ResearchDx to provide independent and unbiased guidance, expert analysis in all areas of the development process.
Our team experience includes:
- Assay development, platform evaluation, and validation
- Management of all levels of regulatory compliance, processes, applications, and approvals
- FDA interface: product life-cycle support / management (program design, pre-IDE, periodic updates, IDE, 5-10k, PMA, defense, post-approval, etc.)
- Technology evaluation: utility, application, fit-for-purpose, and patentability
- Market and competitor (SWOT) analysis
- Mergers and Acquisitions
- Guarantee clinical lab certification
Clinical Laboratory Consulting:
ResearchDx can provide a complete turnkey Clinical Laboratory startup services, or alternatively, we will work with established companies to seamlessly integrate only the components you need into your current framework. ResearchDx specializes in establishing and maintaining CLIA, Accreditation agency (CAP, JCAHO COLA), and appropriate State licensure Clinical Laboratories.
- Turn-Key Laboratory Outsourcing
- Technical and Clinical Consultant Services
- Contract Medical/Laboratory Director
- CLIA and Accreditation (CAP, JCAHO, COLA) Submissions
- State Clinical LaboraPre-Inspection Audit, Interim Inspections, Compliance Reviews
- Post Audit Deficiency Resolution and Plan of Correction
- Accreditation-related SOPs, Policies and Controlled Documents
- Quality Assurance, Process Improvement and Corrective Action Plans
- New Assay Design
- Design and Implementation of Laboratory Automation
- Assay Validation Design and Implementation
- Laboratory Staff Training and Competency
- External QA and QC Data Review
- CPT Coding and Billing Review
- Laboratory Send Out Practice Review
Email your inquiries to consult@researchdx.com