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International Regulatory Consultants

7151 South 700 W., Suite 105
Salt Lake City, UT 84047-7101 USA
Tel: +1 801 233 0075
Fax: +1 801 233 0089

Web: http://www.intregcon.com
E-mail: dfgrabarz@irclc.com

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U.S. DESIGNATED AGENT
and
OFFICIAL CORRESPONDENT

A Trademark Service Of

What We Do:

  • Annual FDA Registration & Device Listing
  • Regulatory Services
  • Coordination with US Importer/Distributor
  • Medical Device Reporting/Complaint Handling
  • US cGMP & Regulatory Systems Analysis/Auditing
  • Quality Systems Services
  • US FDA On-site Inspection Coordination
  • 510(k) Submissions/Premarket Approval Applications
  • IDE Submissions & Clinical Trial Management
  • Strategic and Regulatory Planning
  • Training and Education Services
  • Personnel Training

    How We Work:

    IRC offers a variety of fee based Option Plans to fit each Manufacturers budget and needs, which are proven to be highly cost effective based on the size of the company and the product volume and criticality. We are your mandatory voice in representing you to the U.S. Food and Drug Administration. U.S. Agent/Official Correspondent Services Allow IRC to demonstrate our value to your business.

    IRC Strategic Alliance Partners

  • Q-Med for EU Regluatory and Quality Systems Services
  • Factory for Worldwide Clinical Trial Management
  • BioScan for Full Service pre-clinical laboratory and animal studies
  • MediMark for EU Authorized Representative
  • MedLink Europe for European Marketing Logistics
  • Vector Resources for U.S. Marketing Logistics

    Together with IRC a Strong Team for Success

    European Authorized Representative

    MediMark® Europe headquartered in Grenoble, France and administrative offices in Flemington, New Jersey has joined forces with IRC enhancing services to both existing and new client's with compliance requirements under the present European Medical Device Directives and the NEW In Vitro Device Directive. For details contact IRC.

    Categories this company is listed under in the European Medical Manufacturing Suppliers Directory:

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