International Regulatory Consultants - Regulatory and Quality System Consultants

International Regulatory Consultants (IRC) is an organization of highly qualified professional regulatory and quality system consultants with an average of more than 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 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.

STRATEGIC REGULATORY BUSINESS PLANNING

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 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 / ISO) audit, analysis and design; design assurance and control; preproduction 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.

• Strategic planning from design to market
• Premarket notification 510(k) submissions
• Premarket approval applications
• Investigational device exemptions
• Clinical trial management
• EU IVDMD compliance
• Mandatory medical device reporting
• Master file (DMF) preparation and submissions
• Labeling and advertising review
• Import / export approvals
• FDA representation / official correspondent
• Compliance crisis management
• EU MDD compliance

CE MARK COMPLIANCE SERVICES

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.

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 EEU.

Our affiliation with Vector Resources L.C. in the US enables IRC to help clients find critical path solutions to their marketing, sales and partnering needs.

FDA REPRESENTATION

Our key staff personnel have significant experience in representing clients as US agent and official correspondent before the US Food and Drug Administration. In addition, IRC maintains strategic affiliations on global basis which when necessary enables our organization to fully serve those clients in a shrinking regulatory compliance world.

With proven expertise in US FDA medical device and biotechnology product regulations, current quality systems and GMP regulations, the latest European medical device / in vitro diagnostic device directives, and ISO series quality standards. IRC is the unquestionable choice as a consultancy. This know-how has been placed into practice in our continued demonstration to be in the solution rather than the problem.

MEDICAL DEVICE REGULATORY EXPERIENCE

The IRC staff associates posses the unquestionable expertise and experience to help interpret and advise on US FDA regulatory requirements and to help ensure compliance with the ISO / EN standards and CE mark requirements. Staff qualifications include certification as ISO Lead Auditors.

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.