Services
United States In Vitro Diagnostic Consultants is a full-service consulting firm that specializes in providing a wide range of U.S. Food and Drug Administration (U.S. FDA) and Global Regulatory Affairs services to the In Vitro Diagnostic (IVD) Device, Companion Diagnostic (CDx) Device, Medical Device, Combination Drug/Device, Clinical Laboratory, Biological and Pharmaceutical industries.
Our services include the following:
- U.S. FDA Regulatory Affairs and Global Regulatory Body Strategy and Negiotiations
- U.S. FDA Product Submissions and Approvals (LDT, IDE, 510k, PMA, BLA, IND and NDA)
- Global Regulatory Product Submissions, Approvals and Regulatory Compliance
- U.S. FDA Clinical Trial/Study Protocol Development and Execution
- U.S. FDA Quality System Regulation (QSR/GMP/cGMP/GLP/GCP) Regulatory Compliance
- ISO 13485/ISO 9001 Implementation and Regulatory Compliance
- EU Technical File Development, Product CE Marking and MDD/IVDD Regulatory Compliance
- U.S. FDA and IEC 62304 Software Development Process Implementation and Compliance
- U.S. FDA Establishment Registration and Device Listing
- U.S. CLIA/CAP/New York State Regulatory Compliance
- U.S. CLIA/CAP/New York State Laboratory Developed Test (LDT) Validation, Implementaton and Commercialization
- U.S. FDA/CLIA/CAP/New York State Inspection Readiness
- Mock U.S. FDA and Global Regulatory Body Inspections and Gap Analysis
- U.S. FDA Warning Letter Resolution
- U.S. FDA Consent Decree Resolution