WHY USE A CONSULTANT?
  • KNOWLEDGEABLE AND EXPERIENCED
  • TEMPORARY RESOURCES FOR PROJECTS ON AS-NEEDED BASIS WITH NO
    LONG TERM COMMITMENT.
  • SECOND OPINIONS AND PROGRAM ASSESSMENTS.
PEI PHARMA CONSULTING
EXPERIENCED - PRACTICAL - PROVEN
Pruden Enterprises, Inc. (PEI) has provided consulting services to the pharmaceutical process design,
facility design, construction management, 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 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

c
omprehensive chemistry, manufacturing and controls documentation.
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Consulting to the Pharmaceutical Manufacturing Industry

SERVICES:

ADMINISTRATIVE SUPPORT:
  • DUE DILIGENCE
  • GLP compliant JOB DESCRIPTIONS
  • SALARY PLANS
  • CONTRACT NEGOTIATIONS
  • SUPPLY AGREEMENTS
  • QUALITY AGREEMENTS
  • TECH TRANSFER AGREEMENTS
  • SOP WRITING

PRODUCTS:
  • API SOURCING
  • EXCIPIENT SOURCING
  • COMPONENT SOURCING
  • VENDOR AUDITING AND QUALIFICATION
  • PROCESS IMPROVEMENT
  • STABILITY DESIGN, TESTING AND REPORTING
  • SPECIFICATION DEVELOPMENT

MANUFACTURING AND PACKAGING PROCESSES:
  • PROCESS QUALIFICATION-VALIDATION
  • FACILITY DESIGN
  • SCHEMATIC LAYOUTS
  • A&E QUALIFICATION REVIEW
  • A&E CONTRACT NEGOTIATIONS
  • QUALITY IMPROVEMENTS
  • EQUIPMENT SELECTION, EQUIPMENT SOURCING, FAT SUPPORT, INSTALLATION,
    SAT SUPPORT AND EQUIPMENT QUALIFICATIONS
  •  SUPPLY CHAIN MANAGEMENT

PROJECT MANAGEMENT
  • GANTT TIME LINES
  • COST ESTIMATING
  • MEETING COORDINATION AND FOLLOW-UP
  • CONTRACT COMPLIANCE
  • BUDGET CONTROL

QUALITY ASSURANCE
  • VENDOR QUALIFICATION AND AUDITING
  • FACILITY AUDITING
  • 483/WARNING LETTER REMEDIAL ACTIVITIES
  • REGULATORY RESPONSES AND REMEDIAL ACTIVITIES
  • TECHNICAL WRITING
  • BATCH RECORDS
  • VALIDATION PROTOCOLS AND REPORTS
  • TECH TRANSFER PROTOCOLS and REPORTS