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Leon Lachman, Ph.D. has served since 1978, as President of this consulting organization. As such, LCS has provided regulatory assistance (filings and compliance resolutions), performed GMP, GCP and GLP audits and assistance to enhance conformance, performed numerous Application Integrity Audits (AIP), performed scientific misconduct audits of FDA filings, assisted with computer, process and analytical methods validation, developed validation protocols, developed SOPs for operations, quality assurance and quality control, clinical studies, developed appropriate training programs with effectiveness measures, acted as FDA agent for domestic and foreign firms and performed simulated Pre-Approval Inspections (PAIs). LCS client base consists of innovator firms, generic firms, device and diagnostic firms and biotech firms, domestic and foreign. Dr. Lachman received his Ph.D. from the School of Pharmacy of the University of Wisconsin. He has lectured at various FDA and industry associations, is co-editor of pharmacy / pharmaceutical books, past president of Academy of Pharmaceutical Sciences and past President and Director of Parenteral Drug Associations. | 