|Pruden Enterprises, Inc. (PEI) has provided consulting services to the pharmaceutical manufacturing industry since
1998. PEI has assisted companies with product design, process design, facility design, Project Management, FDA
compliance review, Quality Assurance and implementation of efficient and compliant operations.
PEI has provided guidance and project management for complex technical transfers assuring timely execution of
manufacturing process transfers, equipment transfers, equipment validations, process validations, analytical method
development, analytical method validations, pilot batch manufacturing, registration batch manufacturing and
validation batch manufacturing. PEI supports all submissions through development of comprehensive chemistry,
manufacturing and controls documentation.
Through associations with affiliated consulting firms, PEI can provide Drug Development, Regulatory Affairs and
Clinical Affairs services to meet all FDA and EMEA regulatory requirements.
Through associations with affiliated CMO's, PEI can provide Phase I-III and commercial manufacturing services.
J. Fred Pruden, Principal
Manufacturing, Engineering, Supply Chain Management, Facility Design, Validation, Project management
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