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TYPES OF CONTRACT MANUFACTURERS 9
CORE COMPETENCIES 9
VENDOR 9
CONTRACT RESEARCH ORGANIZATION (CRO) 9
HISTORY OF OUTSOURCING 9
HISTORY OF OUTSOURCING (CONTINUED) 10
HISTORY OF OUTSOURCING (CONTINUED) 11
Chapter-4: CONTRACT MANUFACTURING
NEED FOR CONTRACT MANUFACTURING 12
FLEXIBILITY 12
CAPACITY AND CAPITAL 12
ADVANTAGES OF CONTRACT MANUFACTURING 13
TABLE 1 KEY ADVANTAGES OF CONTRACT MANUFACTURING 13
TABLE 1 (CONTINUED) 14
SELECTION OF CONTRACT MANUFACTURER 14
MISCONCEPTIONS REGARDING CONTRACT MANUFACTURERS 15
Chapter-5: CONTRACT RESEARCH
INCLUDED IN RESEARCH 16
DRUG DISCOVERY AND DEVELOPMENT 16
CLINICAL RESEARCH 17
ANALYTICAL RESEARCH 17
NEED FOR CONTRACT RESEARCH 17
SERVICES OFFERED BY CONTRACT RESEARCH ORGANIZATION 18
SELECTION AND MANAGEMENT OF CRO 18
Chapter-6: CONTRACT PACKAGING
CONTRACT PACKAGING 19
THE NEED FOR CONTRACT PACKAGING 20
CRITERIA FOR THE SELECTION OF A PACKAGING SERVICE 20
LOCATION 21
EXPERIENCE 21
PERSONALITY 21
FINANCIAL STRENGTH 21
ADVANTAGES OF CONTRACT PACKAGING 21
ADVANTAGES OF CONTRACT PACKAGING (CONTINUED) 22
Chapter-7: THE NEED FOR PROJECT MANAGEMENT
PROJECT EVALUATION AND SET UP 23
PLANNING AND EXECUTION 24
QUALITY MANAGEMENT 24
MANAGEMENT OF QUALITY COMPONENTS FROM CLIENT'S PERSPECTIVE 25
MANAGEMENT OF QUALITY COMPONENTS FROM THE CMO PERSPECTIVE 25
Management of Quality Components ... (Continued) 26
Chapter-8: REGULATORY ASPECTS
SHORT SUPPLY ARRANGEMENTS 27
DIVIDED MANUFACTURING ARRANGEMENTS 28
SHARED MANU
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