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A team of GMP Consultants were mandated to set up and manage GMP processes (Deviation, CAPA, Change Control, Batch Record), procedures and training for the new clinical manufacturing areas for high quality proteins and biomolecules at a biotech company. Validation…

In 2019-2020, GMP Consultants was selected to assist a team of experts in Pontoise, FRANCE to implement remediation actions in response to a FDA Warning Letter given to a leading cosmetic company. After 3 months, GMP Consultants was solicited to…