Accela Sciences will act as a U.S. agent for foreign manufacturers of pharmaceuticals for import into the U.S. as required under 21 CFR 207.40,

"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"

for IND filing and maintenance under 21CFR 312.23.

"The signature of the sponsor or the sponsor's authorized representative. If the person signing the application does not reside or have a place of business within the United States, 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."

Or as recommended under the Drug Master Files Guidance, section VII.D,

"When an agent is appointed, the holder should submit a signed letter of appointment to the DMF giving the agent's name, address, and scope of responsibility (administrative and/or scientific). Domestic DMF holders do not need to appoint an agent or representative, although foreign DMF holders are encouraged to engage a U.S. agent."

Accela Sciences will act as a liason between your company and the FDA, facilitate communication, respond to questions concerning your products, and assist the FDA in scheduling inspections of your facility. We will also assist in DMF and dossier preparation and review, and participate in FDA meetings and conference calls.