PROFILE

Who We Are:
International Regulatory Consultants is an organization of highly qualified professional regulatory, clinical and quality system consultants with an average of 25+ years industry / FDA related experience. Founded in 1989, we specialize in helping manufacturers of medical products coordinate North American, European, Asian and Pacific Rim regulatory affairs, clinical trials and quality systems compliance activities. Our clients have and continue to include both large and small companies in the US, Canada, Europe, the Middle East, and Asia.

What We Do:
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 regulatory, clinical trial management and quality system requirements including biocompatibility and microbiological testing. The array of services encompass regulatory product submissions/dossiers for product approvals; planning, administration, analysis, and management of clinical and non-clinical research; 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 regulatory, clinical trial 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 EU Directives and CE Mark requirements. In addition, our affiliation with MedLink Europe, affords our clients both the opportunity and capability of having a highly effective marketing and distribution network, including assistance towards establishing strategic alliances for manufacturing and operations within the EU.

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.

How We Work:
The IRC staff associates posses the unquestionable expertise and experience to help interpret and advise on U.S. FDA regulatory requirements and to help ensure compliance with the ISO / EN Standards and CE Mark Requirements. Our business is service and we take pride in those accomplishments achieved in representing our clients. Our objective in meeting the needs of our clients is focused and results oriented. With operations strategically located, the services of IRC are cost effective, realistic and practical.