Biopharma outsourcing involves a foreign entity partnering with Indian CMOs/service providers for research and development. This chapter discusses the various models employed in biopharma outsourcing and which model is more suitable to which type of business. This chapter introduces the reader to the Indian regulatory framework relating to the biopharma industry, and the likely issues and hurdles which may be faced by the parties during the outsourcing process.
Keywords
research and development (R&D)
product
process
services
goals
models
competitive advantage
cost
strategic partnership
joint venture
captive direct
regulatory environment
authorities
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