- GAIN THE BENEFIT OF PROFESSIONAL EXPERIENCE AND
KNOWLEDGE OF OTHERS.
- TEMPORARY RESOURCES FOR PROJECTS ON AN AS-NEEDED
BASIS WITH NO LONG TERM COMMITMENT.
- SECOND OPINIONS AND PROGRAM ASSESSMENTS.
|EXPERIENCED - PRACTICAL - PROVEN
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, construction management, Project Management, FDA
compliance review, Quality Assurance and implementation of efficient and compliant
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