中国、印度、美国与欧洲被誉为国际原料药市场的四大积极参与者，近些年来， 随着一大批世界畅销级药物专利陆续到期，中国作为其中的生产与出口的大国，有越 来越多的制药企业积极投入到药品研发、生产与出口贸易中。据统计，2019年共有 12,462家国内制药企业生产和出口原料药，比2018年同期增加了1,056家。日本作 为中国原料药出口的第三大贸易国，对中国原料药的需求逐年增加，根据日本药品和 医疗器械局（PMDA）公布的药物注册主文件（MF）数据，截至2020年5月31日： 注册申请API的MF一共4,390项，其中有4,089项来自中国，占比约93％，压倒 性地超过其他国家。中国原料药出口企业也开始积极参与日本市场，中日迎来了双方 制药法规、GMP管理和质量文化交流的关键时期。 作为拓展中日质量管理咨询业务的上海S质量管理咨询公司，本论文以其为研究 对象，通过梳理公司的组织结构和目前的营销现状，探索和构建更合理、完善的组织 体系；此外，分析国内外制药行业GMP、质量管理咨询行业的现状，并运用PEST 外部宏观环境分析和波特五力模型识别上海S质量管理咨询公司的经营风险和营销 环节存在的缺陷，通过波士顿矩阵分析公司产品竞争力和市场增长空间，以4R理论 为导向、以建立长期合作关系为核心，与客户形成互利共赢的合作模式，最终设计并 制定更适合S公司发展的营销策略优化方案，同时检验各种模型和4R理论在新经济 时代下质量管理咨询业应用的普适性。 关键词：营销策略；4R理论；质量管理；GMP III Abstract China, India, the United States, and Europe are known as the four active participants in the international API market. In recent years, as a large number of world-selling drug patents have expired, China, as a major producer and exporter, has more and more pharmaceutical companies are actively investing in drug R&D, production and export trade. According to statistics, a total of 12,462 domestic pharmaceutical companies produced and exported APIs in 2019, an increase of 1,056 from the same period in 2018. Japan, as the third largest trading country of China's API exports, has increased its demand for China's APIs year by year. According to the Drug Registration Master File (MF) data published by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, as of May 31, 2020 , A total of 4,390 MFs registered and applied for API, of which 4,089 were from China. It accounts for about 93%, overwhelmingly more than other countries. Chinese API export companies have also begun to actively participate in the Japanese market. China and Japan have ushered in a critical period for the exchange of pharmaceutical regulations, GMP management and quality culture between the two sides. As the Shanghai S Quality Management Consulting Company, which is expanding the quality management consulting business between China and Japan, this thesis takes it as the research object, through combing the company’s organizational structure and current marketing situation, exploring and constructing a more reasonable and complete organizational system; in addition, analysis The current situation of GMP and quality management consulting industry in the pharmaceutical industry at home and abroad, and using PEST external macro environment analysis and Porter’s five forces model to identify the operating risks and defects of the marketing link of Shanghai S Quality Management Consulting Company, and analyze the company’s product competition through the Boston matrix Strength and market growth space, guided by the 4R theory, with the establishment of long-term cooperative relations as the core, form a mutually beneficial and win-win cooperation model with customers, and finally design and formulate a marketing strategy optimization plan that is more suitable for the development of S company, while testing IV various The universal applicability of model and 4R theory in the application of quality management consulting industry in the new economic era. Keywords: Marketing strategy; 4R theory; quality management; GMP 目录 致谢 .................................................................... I 摘要 ................................................................... II Abstract ............................................................... III 第1章 绪论 ............................................................ 1 1.1选题背景与研究意义 ............................................... 1 1.1.1 选题背景 ..................................................... 1 1.1.2 研究目的 ..................................................... 3 1.1.3 研究意义 ..................................................... 5 1.2 国内外相关研究现状 ............................................... 7 1.2.1 国外相关研究现状 ............................................. 7 1.2.2 国内相关研究现状 ............................................. 9 1.2.3 国内外相关研究现状评述 ...................................... 10 1.3 理论概述 ........................................................ 11 1.3.1 PEST模型理论 ............................................... 11 1.3.2 五力模型理论 ................................................ 11 1.3.3 波士顿分析法 ................................................ 11 1.3.4 4R理论 ..................................................... 11 1.4 研究内容与基本框架 .............................................. 12 1.4.1 研究内容 .................................................... 12 1.4.2 基本框架 .................................................... 12 1.4.3 技术路线 .................................................... 14 1.5 研究方法与创新点 ................................................ 15 1.5.1 研究方法 .................................................... 15 1.5.2 创新点 ...................................................... 15 第2章 上海S质量管理咨询公司营销现状分析 ............................. 16 2.1 公司概况 ........................................................ 16 2.1.1 基本业务 .................................................... 16 2.1.2 组织结构 .................................................... 17 2.1.3 经营业绩 .................................................... 17 2.2 上海S质量管理咨询公司内外部环境分析 ............................ 18 2.2.1 宏观环境PEST分析 .......................................... 18 2.2.2 行业环境五力分析 ............................................ 20 2.2.3 产品波士顿矩阵分析 .......................................... 21 2.2.4 营销策略4R分析 ............................................. 23 2.3 上海S质量管理咨询公司营销模式和市场现状 ........................ 25 2.3.1 目前营销模式介绍 ............................................ 25 2.3.2 质量管理咨询市场需求 ........................................ 26 2.3.3 潜在客户分析 ................................................ 29 2.4 本章小结 ........................................................ 29 第3章 上海S质量管理咨询公司营销问题分析 ............................. 30 3.1 营销现状分析结果 ................................................ 30 3.2 产品结构分析 .................................................... 30 3.2.1 访谈调查的目的和对象 ........................................ 31 3.2.2 访谈问题的设计和访谈过程 .................................... 31 3.2.3 访谈结果和分析 .............................................. 33 3.3 客户满意度调查 .................................................. 34 3.3.1 问卷调查的目的和对象 ........................................ 35 3.3.2 调查问卷的设计和发放 ........................................ 35 3.3.3 调查结果统计与分析 .......................................... 36 3.4 调查总结与发现的问题 ............................................ 41 3.4.1 缺乏整体市场营销策划理念 .................................... 41 3.4.2 客户需求响应速度较低 ........................................ 42 3.4.3 传统营销模式影响客户忠诚度 .................................. 42 3.4.4 客户回报体制不健全 .......................................... 43 3.5 本章小结 ........................................................ 43 第4章 上海S质量管理咨询公司市场营销策略优化方案 ..................... 45 4.1 建立整体的市场营销策划理念 ...................................... 45 4.1.1 培养复合型市场营销人才 ...................................... 45 4.1.2 构建一体化网络营销方式 ...................................... 46 4.