Updated for 2008

I. U.S. Agent for IND Filing & Maintenance

Section 312.23 Title 21 of the Code of Federal Regulations describes the content and format of an Investigational New Drug Application (IND) to be filed with the U.S. Food and Drug Administration (FDA). Section 312.23(a)(1)(ix) states that the cover sheet (Form FDA-1571) must contain "The signature of the sponsor or the sponsor's authorized representative." In those cases where the person signing the FDA-1571 does not reside or have a place of business in the United States the regulation the regulation specifies that "the IND is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the United States."

Biologics Consulting Group, Inc. (BCG) is experienced in providing services as U.S. Agent, as described in 21 CFR 312.23(a)(1)(ix), to both U.S. and non-U.S. based biologics manufacturers. The responsibilities and fees associated with this function are described below:

Terms:

BCG charges a fixed yearly retainer fee of $4,200.00 (USD) per year for functioning as U.S. Agent for issues concerned with filing an IND with the FDA. This fee covers the administrative costs associated with acting as U.S. Agent, such as routine telephone, courier, and mail costs as well as time spend in short communications with the client and/or the FDA. This fee will be prorated based on the month when the agreement is put in place.

All additional services performed as part of functioning as U.S. Agent (document review/preparation, participation in FDA meetings, teleconferences with clients and/or the FDA, photocopying and assembly of INDs, etc.) will be charged at current 2008 BCG hourly billing rates as specified below:

Use of additional BCG consulting services are at the sole discretion of the company.

II. US Agent for Establishment Registration and Listing

The FDA issued a final rule in November 2001 [Federal Registrar notice (.pdf)] requiring foreign establishments whose products are imported or offered for import into the United States to register with the FDA and to identify a United States agent. The new regulation (21 CFR 207.40(c)) states "Each foreign drug establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart C of this part. Each foreign drug establishment shall designate only one United States agent"

BCG will perform the required functions as US Agent for Establishment Registration and Listing for foreign establishments for an annual fee of $2,400.00 (USD), which will include all the administrative functions specified in the new regulation.

III. Orphan Drug Application

BCG can also serve as a U.S. Agent for an Orphan Drug Application for an annual fee of $1,000.