Daniel J. Roberts successfully guides domestic and international clients in the preparation for and management of U.S. Food and Drug Administration (FDA) pre-approval and systems-based inspections.

Daniel evaluates and assesses pharmaceutical quality systems and specializes in detecting and remediating data integrity concerns and evaluating compliant automated manufacturing processes and related computerized systems.

He provides guidance and assists clients in responding to FDA-483 observations, correspondence with regulatory agencies, and mock FDA facility audits.

Daniel has over 18 years of government regulatory and pharmaceutical/biopharmaceutical industry experience. He was an FDA investigator for eight years, including two years as the primary point of contact for conducting pharmaceutical inspections at the FDA India office located at the U.S. Embassy in New Delhi. As a former investigator, Daniel has conducted pre-approval inspections (PAIs) and for-cause investigations and inspections of pharmaceutical manufacturers of human and veterinary sterile and non-sterile finished dosage forms of active pharmaceutical ingredients (APIs) worldwide. He was also the first lead investigator for the first biosimilar inspection conducted by the FDA in India.

Prior to joining the FDA, Daniel worked in the biopharmaceutical / biotechnology industry for eight years, specializing in quality control analysis for large molecule biotherapeutics.