The FDA requires all foreign producers of the above products to: 1) register their facilities, 2) list products they intend to sell in the U.S. and 3) Select a U.S. Agent/FDA contact and give the name to the USFDA.
Voice: 410 793 0484 - Fax: 240 465 0409
MEDICAL REPORTS EXCHANGE (MRx) CAN ASSIST YOU !!!MRx, provides the regulatory and legal support services that your company needs including U.S. Agent/Official Correspondent. MRx has been assisting many clients for more than twelve years. YOU CAN APPOINT ONLY ONE DESIGNATED U.S AGENT TO WORRY ABOUT ALL OF YOUR CUSTOMERS.Basic US Agent Representation : Our basic registration/update fee of US$ 750.00. Includes:
1. File new facility registration/establishment of a product information file (FDA 2891)
2. Product Listing (FDA 2892, 1 ea per product) as of date of registration (more than 5 listings billed at staff rate)
3. Notify FDA that MRx is your U.S. Agent/assist FDA in coordination of inspections
4. Accept service of documents/maintain FDA communications link>
Other Regulatory, Legal and Related Services
o. o Pre-market (510k) notifications (Cheapest and quickest available) o Pre-Market Approval Filings/New Drug Approvals o Medical Device and Medwatch reporting services o QSR (GMP) audits and training o Labeling assistance and advice o Credit check/.bill collection support o o. For food suppliers, food packaging material reports.
Payment Options : o Bank Draft or certified check in U.S. Dollars and with a U.S. Bank. o Wire transfer: Bank of America, T/R# 052001633, Acct.# 003931747659 (Include $25 bank transfer fee.) o ORDER!, below)
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