Company Profile

Many companies desiring to sell Medical devices, Food, Pharmaceuticals, Cosmetics products to the United States, are unaware of the restrictions placed on such goods by the U.S. Food and Drug Administration (USFDA), which has been direct to insure the quality of food, drugs, cosmetics and medical devices sold in the U.S.. MRx is your best asset in insuring that appropriate registrations, listings, and in the case of pharmaceuticals New Drug Approvals (NDA) are obtained.

We specialize in helping you meet new certification/approval requirements. We will need to know your volume of sales in the U.S. for the above mentioned products. If you have already been faced with delays by the U.S. Customs Service, or notified of detention, timing becomes very important. Labeling for food products or assistance with process certification will be minor percentages of the value of product. The cost of most simple NDA's will be less than $ 2000.00 if you have the clinical work done. We can insure natural content of cosmetics before you try to enter the market.

We maintain a presence close to FDA to insure that we are constantly and completely informed of compliance requirements. When we process your documents, if there are USFDA questions, we answer immediately.  No time is lost through mailings, lost documents and incomplete information.

Designated agent package includes the MDR/Certification  package. Designated Agents are subject to increased liability.
MDR/Certification package includes the establishment of compliant files (mirror image of record copy); receipt and processing of all MDR, Complaint, and adverse event reports; filing of MDR's, 5 day reports, baseline reports and supplemental reports plus four hours of factual investigation and travel.
Factual investigation: A determination of the basic facts. It will result in a recommendation to the client of the need for a technical investigation.
MRx will publish on a regular basis a brief review of the current regulatory situation in the U.S. Food and Drug Administration.