DANIEL ROBERTS evaluates and assesses pharmaceutical quality systems and focuses on 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, corresponding with regulatory agencies, and conducting mock FDA facility audits.
Dan has over 20 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, Dan 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 and 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, Dan worked in the biopharmaceutical/biotechnology industry for eight years, focusing on quality control analysis for large molecule biotherapeutics.
*Not admitted to practice law.