Together on the trail to the summit

US Agent

FDA REPRESENTATION

DDC serves as a U.S. Agent for a foreign pharmaceutical company who plans to enter into the US market. DDC acts as an adjunct to your company’s Regulatory Affairs unit.

DDC is an experienced US representative registered with FDA. DDC has proven knowledge of the regulatory requirements that must be effectively and rapidly communicated by a foreign company to the FDA to be in compliance with the agency’s regulations. These timely responses prevent a possible FDA mandated clinical hold.

In addition, DDC submits for you appropriate documentation for a variety of regulatory issues related to guidance meetings, annual reports, CMC updates, and periodic reviews of nonclinical and clinical findings.