Contract Research and Manufacturing Services (CRAMS) in India
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Contract Research and Manufacturing Services (CRAMS) in India

The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors
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ISBN-13:
9781908818164
Einband:
EPUB
Seiten:
248
Autor:
Milind Antani
Serie:
Woodhead Publishing Series in Biomedicine
eBook Typ:
Adobe Digital Editions
eBook Format:
EPUB
Kopierschutz:
Adobe DRM [Hard-DRM]
Sprache:
Englisch
Beschreibung:

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 diagramsPractical tips from leading practitionersInclusion of relevant case laws and other legal considerations
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 diagramsPractical tips from leading practitionersInclusion of relevant case laws and other legal considerations

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