About Us
United States Food and Drug Administration Compliance Group is a full-service consulting firm that specializes in providing a wide range of United States Food and Drug Administration (U.S. FDA) and Global Regulatory Affairs services to the Medical Device, In Vitro Diagnostic (IVD) Device, Companion Diagnositc (CDx) Device, Combination Drug/Device, Clinical Laboratory, Biological and Pharmaceutical industries.
Our Services
Our services include the following:
- U.S. FDA Regulatory Affairs and Global Regulatory Body Strategy and Negiotiations
- United States 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