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Executive, Senior Level Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs consultant with a Ph.D. in Organic Chemistry and Regulatory Affairs Professional Society (RAPS) Certification. CMC Regulatory Sciences expert with demonstrated expertise in obtaining FDA and EMA regulatory approvals to market novel and innovative pharmaceutical drugs. Strategic CMC Regulatory Sciences consulting services ( on drug substance and drug product at all phases of the Investigational New Drug (IND) development, the New Drug Application (NDA) planning and submission to approval and for the maintenance of NDA Post-Approval, Life Cycle, regulatory CMC Compliance and Conformance.