Contract Research and Manufacturing Services (CRAMS) in India

The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Contract Research and Manufacturing Services (CRAMS) in India by , Elsevier Science
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Author: ISBN: 9781908818164
Publisher: Elsevier Science Publication: October 31, 2012
Imprint: Woodhead Publishing Language: English
Author:
ISBN: 9781908818164
Publisher: Elsevier Science
Publication: October 31, 2012
Imprint: Woodhead Publishing
Language: English

The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications.

  • Simple and accessible presentation using tables, charts and diagrams
  • Practical tips from leading practitioners
  • Inclusion of relevant case laws and other legal considerations
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The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications.

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