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Submission tactics

机译:提交策略

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Despite the inability of some countries to accept electronic submissions, many companies continue to pursue the oursourcing of eCTDs. Mr. Chung says the reasons for this trend include resource constraints, lack of expertise with new regulations, an inability for a company to invest in new processes and solutions to manage electronic submissions, management mandate, and virtual company model. As the trend progresses, Mr. Chung believes there is opportunity for companies to maintain and own the drug-development process but not necessarily undertake the submission process. This option has the potential to dramatically reduce administrative overhead, Mr. Chung says.
机译:尽管某些国家/地区无法接受电子提交,但许多公司仍在继续寻求eCTD的外包。 Chung先生说,造成这种趋势的原因包括资源紧张,缺乏新法规方面的专业知识,公司无力投资新流程和解决方案来管理电子提交,管理任务和虚拟公司模型。钟先生认为,随着趋势的发展,公司有机会维持并拥有药物开发过程,但不一定要进行提交过程。钟先生说,这种选择有可能大大减少管理费用。

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