Updated for 2012

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 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.”

U.S. Agent for Orphan Drug Designation

Section 316.20 Subpart C Title 21 of the Code of Federal Regulations describes the procedures for submitting a request for Orphan Drug Designation (ODD) and describes the requirements for an official correspondent and a resident Agent to facilitate communications between the sponsor and the FDA.

U.S. Agent for Establishment Registration and Listing

Sections 207.40c and 807.40 of Title 21 of the Code of Federal Regulations specify that any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment.

BCG is experienced in providing services as U.S. Agent, as described in:

21 CFR 312.23(a)(1)(ix) for INDs
21 CFR 316.20, for Orphan Drug Designations
21 CFR 207.40, for foreign establishments and
21 CFR 807.40, for devices

to non-U.S.- and U.S.-based biologic drug and device manufacturers who elect such services. The responsibilities and fees associated with this function are described below:

Terms:

BCG shall act as an intermediary between the sponsor and the FDA such that communication associated with an application or Establishment Registration is facilitated.  As such, BCG’s main responsibility is to provide assured access to both the sponsor and to the FDA, and to provide quick, reliable transmittal of communications and to document all such communications.  BCG will assign a primary and secondary US Agent contact for each application under this Agreement.

BCG charges a fixed yearly fee for functioning as U.S. Agent as specified below:

BCG charges a one-time fee for pre-IND services (meeting requests, briefing packages, etc.) of $1,000 USD.

This fee will be prorated based on the month when the agreement is put in place. Services performed once BCG is designated as a U.S. Agent including but not limited to liaising with FDA, document review/preparation, participation in FDA meetings, teleconferences with you and/or the FDA, and publishing of application documents will be charged at current BCG hourly billing rates.  The rates specified below will be effective through December 2012 and are subject to change yearly thereafter. 

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