USA: International Regulatory Consultants, L.C.

IRC offers a complete range of services which include highly important strategic regulatory business planning. IRC maintains strategic operations to help service our European and Asian clients with a variety of services for clinical, regulatory and quality system requirements including pre-clinical safety, biocompatibility and microbiological testing. The array of services encompass clinical research, planning, administration, analysis, and management of clinical and non-clinical studies; regulatory product submissions/dossiers for product approvals; quality systems (GMP/QSR/ISO) audit, analysis and design; design assurance and control; pre-production technology transfer and validation; compliance crisis management, including FDA inspection issues, FDA Warning Letters, detention, injunctions, and consent decree requirements; and, training programs for both regulatory and quality systems.

Our collaboration with certain highly qualified and cost effective European based consulting firms to provide service as a required Authorized Representative affords our clients the opportunity to utilize IRC services along with that of the Authorized Representative to help ensure compliance with CE Mark requirements.  Our affiliation with Vector Resources L.C. in the U.S. enables IRC to help clients find critical path solutions to their marketing, sales and partnering needs.

CRO SERVICES

Clinical Trial Management
• Study Design
• Study Site Selection
• Regulatory Submission/Approval
• Study Initiation
• Monitoring
• Data Acquisition/Analysis
• Biostatistics
• Regulatory Reporting

REGULATORY SERVICES
• Strategic Planning from Design to Market
• Premarket Notification 510(k) Submissions
• Premarket Approval Applications
• Investigational Device Exemptions
• EU MDD / IVDMD Compliance
• Complaint System
• Mandatory Medical Device Reporting
• Master File (DMF) Preparation and Submissions
• Labeling and Advertising Review
• mport/Export Approvals
• FDA Representation/Official Correspondent
• Compliance Crisis Management

QUALITY SYSTEMS SERVICES
• US Quality Systems / Good Manufacturing Practices
• ISO/ EN Standards
• Verification and Validation
• FDA Inspection Coordination
• Vendor Audits

U.S. AGENT/OFFICIAL CORRESPONDENT SERVICES
• Medical Device Reporting Complaint Handling Management
• Coordination with US Importer/Distributor
• Annual Facility Registration & Listings
• QSR / GMP & Regulatory Systems Analysis/Auditing
• 510(k) / PMA / IDE Submissions
• NDA / ANDA / IND Submissions
• Clinical Trial Management
• FDA Inspection Coordination
• Strategic and Regulatory Planning
• Personnel Training

TRAINING AND EDUCATION SERVICES
• Regulatory Administration
• US Quality Systems Administration (cGMP)
• Complaint Handling Systems
• Document Control / Design Control Practices
• Regulatory Submissions