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Outsourcing biopharma R & D to India /
The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R & D was inclined more towards developing products for the Indian mar...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Oxford ; New York :
Biohealthcare,
2011.
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| Colección: | Woodhead Publishing series in biomedicine ;
no. 2. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover; Woodhead Publishing Seriesin Biomedicine; Outsourcing biopharma R & D to India; Copyright; Contents; Acknowledgements; About the author; 1 Biopharma outsourcing in India: its evolution; 1.1 What is outsourcing?; 1.2 What is R & D?; 1.3 Organisational patterns in R & D outsourcing; 1.4 R & D outsourcing in the pharmaceutical industry; 1.5 India as the emerging hub of R & D outsourcing in the pharmaceutical industry; 1.6 Outsourcing models prevalent in India: cooperation models for outsourced services; 1.7 Key issues involved in outsourcing; Notes.
- 2 India's core competitive advantage in R & D in the biopharma sector: the impetus for outsourcing2.1 Introduction; 2.2 Cost competitiveness; 2.3 Resources and skill; 2.4 The role of the government; 2.5 Conclusion; Notes; 3 Different modes of outsourcing biopharma R & D to India; 3.1 Indian companies involved in outsourcing activities; 3.2 Contract research services; 3.3 Contract manufacturing organisations; 3.4 Drug substance manufacturing; 3.5 Drug product manufacturing; 3.6 Process development; 3.7 Analytical methods and characterisation.
- 3.8 Business models for contract manufacturing organisations3.9 Insights into outsourcing of product development and manufacture; 3.10 Clinical trials; 3.11 Advantages and disadvantages of doing clinical trials in India; 3.12 Active pharmaceutical ingredient and technology transfer; 3.13 Conclusions and implications; Notes; 4 The Indian regulatory environment: a historical perspective; 4.1 Indian Council for Medical Research; 4.2 Central Drugs Standard Control Organisation; 4.3 Department of Biotechnology; 4.4 National Pharmaceutical Pricing Authority; 4.5 Overview of the industry; Notes.
- 5 Implications of the changing regulatory environment in India5.1 Introduction; 5.2 Capacity Building Programme: recent development5; 5.3 Clinical Trials Registry
- India; 5.4 The Indian Society for Clinical Research; 5.5 Conclusion; Notes; 6 Creating contracts for outsourcing in the biopharma industry; 6.1 Biopharma outsourcing; 6.2 Preliminary documentation; 6.3 Drafting of the biopharma outsourcing agreement; 6.4 Specific considerations in different types of agreements; 6.5 Conclusion; Notes; 7 Environmental, health and safety guidelines and biopharma outsourcing: an Indian perspective.
- 7.1 Introduction7.2 The environmental, health and safety guidelines; 7.3 EHS guidelines and India; 7.4 Challenges faced by Indian companies in EHS compliance; 7.5 Conclusion; Notes; 8 Certifications; 8.1 Introduction; 8.2 Certifications; 8.3 Manufacturing licence; 8.4 Good Manufacturing Practices; 8.5 No-Objection Certificate and Certificate of Origin; 8.6 Certificate of a Pharmaceutical Product; 8.7 Certifications for clinical trials; 8.8 International regulatory certifications; 8.9 Conclusion; Notes; 9 The need for due diligence of service providers; 9.1 Introduction.