MRx

DEALING WITH

THE

U. S. GOVERNMENT

ON

REGULATORY

AFFAIRS

MEDICAL REPORTS EXCHANGE

Compliance, Liaison, Education

Representation and Investigation

ForThe Medical Device/Food Industry/Pharmaceutical/Blood Industries

The accelerated growth and sophistication of regulatory requirements are placing new and more stringent demands on manufacturers of pharmaceuticals, foods, medical devices and blood products. Our company goal is to insure that our client successfully deals with the current and future U. S. regulatory complexities. We provide a full range of regulatory support activities. Furtner, changes to 21CFR parts 207, 607 and 807 require that every manufacturer and owner oprator of manufacturers of pharmaceuticals, medical devices, and blood products must appoint a U. S. Agent for regulatory affairs, and report the name and address of this individual to the USFDA.

Many companies desiring to sell devices, pharmaceuticals/food/cosmetic products to the United States, are unaware of the restrictions placed on such goods. The U.S. Food and DrugAdministration (USFDA) is charged by the congress to insure the quality of food, cosmetics,drugs and medical devices sold in the U. S.

MRx is a Designated US Agent registered with the FDA as an MDR Certification Reporting site and U. S. Agent. As professional consultants, we can act as your voice in Washington DC. We are in constant contact with the regulators. MRx specializes in insuring that our clients are in full compliance with all U.S. regulatory requirements, and that they are kept informed as to what is happening in Washington DC. We try to do all of this at a price that even the company with limited activity can justify.

We provide a variety of services in support of our foreign clients which are also available to domestic clients such as Risk Management, tracking and file maintenance, translation services, 510k and PMA preparation and filing in client name. For our U.S. clients we have established access to European agencies and market services and assistance with ISO 9000.

We have established a seamless program for providing our support to corporate and legal customers who do not desire to lose control of the care of their of their clients but do not feel that the costs of establishing a comprehensive in house U.S. Agent support capability is justified. Companies with multiple foreign suppliers may desire to protect themselves from the potential liabilities which result from their acceptance of service of legal documents for companiew with which they desire to maintain some legal separation.

We offer years of experience in the medical, regulatory, legal and investigative fields, tempered with a sound background in the international market place.

Many companies who desire to sell pharmaceuticals blood products or food products to the United States, are unaware of the restrictions placed on products by the USFDA, which has been directed to insure the quality of food, drugs and medical devices sold in the U. S. MRx is also your best asset in insuring that your labeling is correct, and that appropriate registrations, listings, and in the case of pharmaceuticals New Drug Approvals (NDA) are obtained.

WE SPECIALIZE IN HELPING CLIENTS MEET THE NEW 803 CERTIFICATION REQUIREMENTS.

We will need an idea of your wholesale sales in the U. S. for food & pharmaceuticals quotes. If you have already been faced with delays by the U. S. Customs Service, or notified of detention by the USFDA, timing becomes very important. Food products do not store well. Neither do pharmaceuticals. 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 $5000.00 if you have the clinical work done.

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.

For the foreign client, compliance with U.S. regulations is essential to selling in the U.S. For the Domestic client, compliance is essential to doing business. Failure to comply can cost so much more than the cost of compliance.

Basic Services

• Annual reg./listing prod/facilities,
• Audit of client's FDA filings.
• Official correspondent FDA matters.
• Acceptance of legal svc of documents including FDA communications.
• QSR Support/Training/pre-inspection.
• MDR Cert. pack.
• Coordination of FDA Inspections.
• Maint/filing of record copy of MDRs.
• Required reports/filings
• Non-technical investigative service.
• Credit/debt collection assistance.

Consultant services are domestic and international. International services may be subject to specific FDA inspection.

The Designated US Agent/Certification package may include maintenance and filing of record copy of MDR files.

Non-technical investigative services are offered to both domestic and foreign clients, hourly rate does not include direct costs, but does include overhead. Cost of technical investigative assets will be provided on a case by case bid basis.

Prices subject to unannounced change. See check our cost page for details.

A monthly retainer package is available to customers with considerably FDA interface requirements. Along with other responsibilities it includes the MDR/Certification package.

The MDR/Certification package includes the establishment of complaint files (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 (4) hours of factual investigation and travel. Since the Designated US Agent copy of complaint files is also an official copy, clients must agree to provide copies of all complaints, adverse events or foreign equivalent MDR's to the agent for file and record purposes on a timely basis.

QSR/MDR support packages are subject to increased liability.

Factual investigation includes a determination as to the basic facts and will result in a recommendation to the client with regard to the need for or conduct of 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.

MRx believes compliance is a matter of constant study, research and communication. The ability to deal with a variety of clients on a professional level requires the utmost in discretion. Each MRx agreement includes as a basic element of the agreement a statement of strict confidentiality. Under U. S. Law, MRx is subject to both civil and criminal penalties for release of client private or proprietary information.

In conformance with FDA guidance, MRx, as a registered designated agent must maintain the same standards of good manufacturing practice as its' clients. MRx files are subject to un-announced inspections and audit by the FDA as are those of U. S. Manufacturers.

Compliance is the pursuit of excellence through painstaking attention to detail..

For the larger company, importers and distributors, MRx offers programs to assist you to accomplish the tasks required since the implementation of the New Rule. Our professional approach to registration, listing, report filing and state of the art communications provide a compliance solution at a very reasonable price. Please call us for details and prices.

MRx also provides continuing education programs in technical areas relevant to the work we do. Contact us for information on custom programs for you. We use major U. S. Medical training facilities as our resource for these programs. 04/04/00

Web Page: www.mrxinc.com