Outsourcing Biopharma R&D to India

<p>Acknowledgements</p> <p>About the author</p> <p>Chapter 1: Biopharma outsourcing in India: its evolution</p> <p>Abstract:</p> <p>1.1 What is outsourcing?</p> <p>1.2 What is R&D?</p> <p>1.3 Organisational patterns in R&D outsourcing</p> <p>1.4 R&D outsourcing in the pharmaceutical industry</p> <p>1.5 India as the emerging hub of R&D outsourcing in the pharmaceutical industry</p> <p>1.6 Outsourcing models prevalent in India: cooperation models for outsourced services</p> <p>1.7 Key issues involved in outsourcing</p> <p>Chapter 2: India’s core competitive advantage in R&D in the biopharma sector: the impetus for outsourcing</p> <p>Abstract:</p> <p>2.1 Introduction</p> <p>2.2 Cost competitiveness</p> <p>2.3 Resources and skill</p> <p>2.4 The role of the government</p> <p>2.5 Conclusion</p> <p>Chapter 3: Different modes of outsourcing biopharma R&D to India</p> <p>Abstract:</p> <p>3.1 Indian companies involved in outsourcing activities6</p> <p>3.2 Contract research services</p> <p>3.3 Contract manufacturing organisations</p> <p>3.4 Drug substance manufacturing</p> <p>3.5 Drug product manufacturing</p> <p>3.6 Process development</p> <p>3.7 Analytical methods and characterisation</p> <p>3.8 Business models for contract manufacturing organisations</p> <p>3.9 Insights into outsourcing of product development and manufacture</p> <p>3.10 Clinical trials</p> <p>3.11 Advantages and disadvantages of doing clinical trials in India</p> <p>3.12 Active pharmaceutical ingredient and technology transfer</p> <p>3.13 Conclusions and implications</p> <p>Chapter 4: The Indian regulatory environment: a historical perspective</p> <p>Abstract:</p> <p>4.1 Indian Council for Medical Research</p> <p>4.2 Central Drugs Standard Control Organisation</p> <p>4.3 Department of Biotechnology</p> <p>4.4 National Pharmaceutical Pricing Authority</p> <p>4.5 Overview of the industry</p> <p>Chapter 5: Implications of the changing regulatory environment in India</p> <p>Abstract:</p> <p>5.1 Introduction</p> <p>5.2 Capacity Building Programme: recent development5</p> <p>5.3 Clinical Trials Registry – India11</p> <p>5.4 The Indian Society for Clinical Research12</p> <p>5.6 Conclusion</p> <p>Chapter 6: Creating contracts for outsourcing in the biopharma industry</p> <p>Abstract:</p> <p>6.1 Biopharma outsourcing</p> <p>6.2 Preliminary documentation</p> <p>6.3 Drafting of the biopharma outsourcing agreement</p> <p>6.4 Specific considerations in different types of agreements</p> <p>6.5 Conclusion</p> <p>Chapter 7: Environmental, health and safety guidelines and biopharma outsourcing: an Indian perspective</p> <p>Abstract:</p> <p>7.1 Introduction</p> <p>7.2 The environmental, health and safety guidelines</p> <p>7.3 EHS guidelines and India</p> <p>7.4 Challenges faced by Indian companies in EHS compliance</p> <p>7.5 Conclusion</p> <p>Chapter 8: Certifications</p> <p>Abstract:</p> <p>8.1 Introduction</p> <p>8.2 Certifications</p> <p>8.3 Manufacturing licence</p> <p>8.4 Good Manufacturing Practices</p> <p>8.5 No-Objection Certificate and Certificate of Origin</p> <p>8.6 Certificate of a Pharmaceutical Product</p> <p>8.7 Certifications for clinical trials</p> <p>8.8 International regulatory certifications</p> <p>8.9 Conclusion</p> <p>Chapter 9: The need for due diligence of service providers</p> <p>Abstract:</p> <p>9.1 Introduction</p> <p>9.2 Sources utilised prior to due diligence</p> <p>9.3 Areas of due diligence</p> <p>9.4 Due diligence process</p> <p>9.5 Contents of the due diligence report6</p> <p>9.6 Conclusion</p> <p>Index</p>