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Provides services that are compliant with global agencies and reflect current industries practise. Several useful industry links,. Including organization and specific documents, are listed below. FDA US. Food and Drug Administration. EMEA European Medicines Agency. MHRA Medicines and Healthcare Products Regulatory Agency (U.K.). PDA - Parenteral Drug Association. USP - U.S. Pharmacopei a. FDA: Points to Consider in the Manufacture and Testing. of Monoclonal Antibody Products for Human Use.

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Process Validation Services

http://www.biotechlogic.com/services/process-validation

Leadership and Senior Consultants. Our Team of Senior Consultants. Process Development and Quality by Design. Synthesis, Fermentation and Cell Culture Processes. When the process technology is defined and the manufacturing documentation accurately reflects the developed production steps, the process is ready to move into the Process Qualification Stage. BioTechLogic has expertise in managing all stages of process validation. Process Validation consists of three critical stages:. Stage 1 Process Design.

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