Retired Pharmaceutical CM&C professional with experience in development from early formulation, scale up, clinical supplies manufacture, registration stability, validation and launch of commercial product. Familiar with ICH, FDA, EMEA, MHRA regulatory requirements and guidances. I have prepared CMC sections for regulatory submissions ranging from IND's and IMPD's to NDA's and MAA's as well as responses to regulatory inquiries. Multiple approvals including NDA's, MAA's, NDS, JNDA.Specialties: Experience managing CMO's and CRO's for GMP and GLP manufacture and analytical of drug substance and drug product for all clinical phases and commercial production.