Serving the Healthcare Industry

International Regulatory Consultants (IRC) provides its services to medical device, in-vitro diagnostic, biotech and pharmaceutical manufacturers to help navigate the complex world of regulations. Our primary focus in the regulatory world targets the U.S. Food and Drug Administration and the growing complexities in the international marketplace. Whether you are a startup or a large multinational company you can benefit from the experience and expertise of IRC to meet your objectives in a highly cost effective and often creative way. Our organization of highly qualified professional consultants will tailor a plan to meet your objectives. Our services are not only designed to gain Government approvals for your products - but to help ensure that your products remain in the marketplace.

Important to clinical trials is the ground work before you start. IRC is positioned to help with those much needed in-vitro and in-vivo pre-clinical studies. We also work with our clients for those all but necessary and important pre-clinical meetings with the Food and Drug Administration prior to any submission applications for trial approvals. Critical to the conduct of any clinical trial is Safety Monitoring. IRC offers an independent review of your trial data to help ensure the protections of human subjects and the integrity of the study.

Many small and startup companies often cannot afford the same advantages that larger companies have. IRC is positioned to act as your Regulatory and/or Quality Assurance department with significant cost savings until you can provide your own in house staff. This service is typically provided "on call" for when you have need.