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重点地区

中国中国香港新加坡印度尼西亚尼日利亚加纳马来西亚柬埔寨越南

解决方案

探索针对不同行业与地区商业挑战的定制化解决方案

反倾销反补贴及其他贸易救济服务

支持反倾销、反补贴、保障措施等贸易救济调查与应诉，协助证据准备、问卷答复及听证策略。

反垄断申报

提供经营者集中申报方案与材料准备，沟通监管机关并协调补救措施，确保及时取得反垄断批准。

审计

提供法定及专项审计服务，支持财务报表审计、内控评估与监管/投资人报告需求。

借壳上市/反向收购

提供借壳上市/反向收购方案设计与落地支持，涵盖壳资源筛选、交易架构、监管路径与信息披露合规。

中国ODI核准/备案

协助完成中国对外投资ODI核准/备案及相关外汇流程，对接发改、商务等主管部门，确保全程合规。

海关合规服务

提供海关合规咨询，涵盖归类、估价、原产地规则、稽核应对与风险防控，提升通关效率与合规水平。

网络安全与数据保护

提供网络安全与数据保护合规建议，涵盖制度治理、应急预案、整改落地及数据跨境传输合规。

争议解决

提供商业争议解决服务，涵盖谈判、调解、仲裁与诉讼，制定策略并进行全流程案件管理。

尽职调查

开展法律、财务、税务与合规尽调，识别重大风险与交易障碍，支撑决策与交易架构设计。

环保

提供环保合规咨询，涵盖环评与许可、EHS管理及可持续要求，评估并整改环境风险。

出口管制与合规服务

建立出口管制合规体系，开展物项分类、主体筛查与许可管理，并应对执法调查，降低跨境合规风险。

东道国投资审批

协助办理东道国投资审批及行业许可，涵盖外资审查、牌照申请与登记备案，保障项目顺利落地。

人力资源

提供人力资源咨询，涵盖招聘用工、薪酬激励、制度建设与劳动合规，并支持跨境派遣与组织优化。

首次公开发行并上市

提供IPO筹备与上市全流程支持，涵盖治理完善、合规整改、申报文件支持及中介协调。

破产与重组

提供破产程序与重组方案咨询，涵盖债权人沟通、债务重整与资产处置，提升价值回收与经营延续性。

国际工程承包

提供国际工程承包（EPC）全链条支持，涵盖投标策略、合同起草谈判、索赔管理与合规风控。

国际物流

提供国际物流方案设计与协调，优化线路、成本与时效，并结合贸易条款与通关要求进行风险管控。

投资协议起草审阅

起草、审阅并协商投资协议（意向书、股权/资产购买及股东协议等），明确权责、控制安排与交割条件。

投资标的筛选与匹配服务

通过行业梳理、财务筛选与匹配度评估，筛选并匹配投资标的，形成高质量项目储备。

法律实体设立与存续

提供设立到存续全流程服务，涵盖注册登记、公司秘书、治理更新与年度申报，确保持续合规运营。

生命科学

提供生命科学领域合规与交易支持，涵盖准入监管、临床与质量合规、许可备案及行业专项风控。

常年法律顾问

提供常年法律顾问服务，覆盖日常咨询、合同审阅、合规支持与紧急事项响应，保障经营稳定。

其他贸易相关服务(贸易融资、贸易保险、报关报检、贸易代理、出口退税、产品认证与检测服务)

提供贸易融资、贸易保险、报关报检、贸易代理、出口退税及产品认证与检测等综合贸易配套服务。

证券/基金/期货/保险/信贷

提供证券、基金、期货、保险及信贷等金融业务咨询，涵盖牌照申请、合规运营、产品结构设计与监管报告。

税务筹划

规划税收高效架构，妥善处理转让定价与双重征税，支持申报与落地，降低税负并确保合规。

技术与知识产权

提供技术与知识产权战略支持，涵盖布局规划、申请维护、许可与转让安排，保护核心创新成果。

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Global Reach

China’s changing regulatory environment and increasingly competitive landscape require medical device companies to develop a localized strategy to enter the Chinese market. As China's leading medical device CRO (including IVD), our expertise and enriched project experiences can help our clients to navigate cultural differences, monitor regulatory changes, and marketize our clients’ products in the most efficient and cost-effective way. Since 2000, we have collaborated with top 20 global medical device companies and worked with more than 600 clients overseas to successfully launch their products in China. Globally, Tigermed-Jyton have established long-term cooperation with more than 1900 medical device R&D and manufacturing enterprises from more than 30 countries, and have set up more than 180 global offices worldwide. With our SOPs and QMS complying with global standards, we offer regulatory affairs and clinical trial services in all major markets. We have global teams of specialists and professionals expertizing in local regulations. With a solid team based in China, Tigermed-Jyton has cost advantages, offering top-tier services such as global study clinical operation, data management & biostatistics, medical affairs, and more.

泰格捷通（北京）医药科技有限公司

IVD——Product Manufacturing and Quality System

We provide the following product production and quality system related services: 1. MAH policy consultation 2. ISO 13485 and ISO 9001 certification guidance 3. Full lifecycle quality system service 4. GMP workshop design counseling and on-site review 5. Product production and quality control under the GMP environment 6. Third-party audit of quality systems 7. Computer information management system 8. Risk management guidance: Registration application and post-marketing follow up study

泰格捷通（北京）医药科技有限公司

IVD——Clinical Trial Services

We are experienced in providing clinical trial services for IVDs. In accordance with current regulations, GCP and corresponding guidelines, we can provide clinical trial related services for: 1. Registrational clinical trial 2. Real-world study 3. Analysis performance studies 4. Reference range studies 5. Exploratory clinical studies 6. Product R&D stage and post-market clinical studies 7. Registrational clinical evaluation Related services cover: 1. Product clinical study design 2. Third-party audits 3. Clinical trial project management and tracking 4. Data management and EDC software system 5. Clinical trial statistics support 6. Clinical trial report writing

泰格捷通（北京）医药科技有限公司

IVD——China and Global Registration Services

Reflected in policies and regulations, different countries have different risk classifications and review requirements for IVDs. The reform of the review and approval system for IVDs is deepening constantly in China. With the industry development, global promotion of products speeds up, and the need of global distribution of products increases continuously. As a global CRO, Tigermed-Jyton can provide regulatory support for China NMPA and global registration for the IVD products. Services related to product registration, covering various risk levels, including initial registration, changes, and certificate extensions: 1. Preparation of product technical requirements 2. Product registration testing / third-party testing 3. Preparation of product registration dossiers and pre-evaluation / third-party pre-evaluation 4. Evaluation process tracking, coordination and communication 5. Preparation and feedback of supplementary information

泰格捷通（北京）医药科技有限公司

IVD——Agent Related Services

We can serve as customer’s legal representative to handle product registration / filing, post-marketing regulatory activities, and communication with relevant authorities. We have a history of over a decade in providing agent services and has developed a comprehensive and mature process with extensive experience in this field. We offer the following services: 1. Assist in communication with the corresponding regulatory authorities 2. Convey regulations and standards to manufacturing company 3. Collect post-marketing AEs and report them to authorities / manufacturers 4. Assist in handling recalls and report to authorities 5. Assist manufacturers in handling other post-market regulatory tasks

泰格捷通（北京）医药科技有限公司

IVD——Product Classification Service

Each country implements classified and graded management for products with different risks. The regulation and control over the full life cycle of the products, including R&D, manufacturing, operation, registration and clinical use, are different for products in different categories. To avoid over or insufficient management caused by ambiguous product classification, and to provide references for reasonable and efficient resource allocation for the enterprise and regulatory authorities, we provide the following product classification service for enterprises. 1. Classification documents preparation guidance 2. Track the application process

泰格捷通（北京）医药科技有限公司

IVD——Regulatory Consultation Service

At present, relevant policies and regulations on medical devices change frequently globally and requirements are becoming increasingly stringent, leading the increasing compliance cost. We provide full lifecycle regulatory services on IVD products for the client and promote product compliance. 1. China and global regulatory consultation 2. China and global regulatory training and interpretation 3. Strategy design and assessment 4. Regulatory update

泰格捷通（北京）医药科技有限公司

IVD——Product Design and Development

Our IVD team has rich experience in serving the innovative development of IVD products. We can provide customers with regulatory and systematic services during the product design and development stages. 1. Establishment of the R&D quality system 2. Product registration strategy (Product development consultation report) 3. Input and output support during the R&D stage 4. Product verification and design validation 5. Technical documentation guidance 6. Design translation guidance 7. Analysis Performance studies 8. Reference range studies 9. Exploratory clinical studies

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Global Medical Device Registration

We have offices around the world, and have maintained close contact with the local authorities. Through analyzing the specific cases of medical devices companies and manufacturers, we provide more direct and professional guidance, along with reasonable marketing strategies. We offer professional medical device registration services globally and is currently committed to the registration approval certification of CE (MDR, IVDR, PPE, AIMDD), FDA (listed, 510K, PMA), Japan, South Korea and other countries.

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——China NMPA Registration Services

Medical devices, which are / will be marketed and used in the People’s Republic of China, shall be registered / filed with the NMPA / local authorities. We can recommend the product registration path for companies, formulate the most reasonable marketing strategy, give warning to possible risk points in advance, and provide reasonable suggestions for risk avoidance to improve the efficiency and to increase success rate of product approval. We can provide you with the proper services regardless of the status of the product. Our services include but not limited to: 1. Product Classification Application / Attribute Application 2. Class I device filing / change filing 3. Class II / III device initial registration 4. Class II / III device renewal registration 5. Change filing of Class II / III device 6. Change registration of Class II / III device 7. Clinical trial application 8. Intent for Use (IFU) changes 9. Medical device certificate re-issuance / error correction / cancellation 10. Other green channel applications, such as innovation application, priority review, emergency use approval, etc

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Agent Related Services

We can serve as customer’s legal representative to handle product registration / filing, post-marketing regulatory activities, and communication with relevant authorities. We have a history of over a decade in providing agent services and has developed a comprehensive and mature process with extensive experience in this field. We offer the following services: 1. Assist in communication with the corresponding regulatory authorities 2. Convey regulations and standards to manufacturing company 3. Collect post-marketing AEs and report them to authorities / manufacturers; 4. Assist in handling recalls and report to authorities 5. Assist manufacturers in handling other post-market regulatory tasks 6. Preparation of annual risk assessment reports 7. Assist in handling random market inspections 8. Assist in handling medical insurance consumables system management and post-market regulatory support 9. Advertising approval 10. Assistance in processing UDI code registration

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Regulatory Consultation

If medical device manufacturers / agents / distributors have any pre-market system, registration, clinical, and post-market regulatory queries, we can provide professional regulatory consultation service. We will comprehensively consider the possible risks involved in all aspects of the queries raised, integrate the relevant resources of the company, help customers consider the overall situation, and avoid subsequent hidden problems. 1. System / Registration / Clinical Query Clarification 2. Strategy planning 3. Regulation and policy interpretation 4. Testing consultation 5. Registration documentation review

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Third-party Audit

We have a complete quality management system for clinical trials of medical devices. Our audit team has an average industry experience of over 10 years. Our audit team members not only possess practical experience in the industry but also come from diverse backgrounds, including hospital institutions and national agencies. This allows us to conduct thorough evaluations of projects from a professional standpoint. The audit team is familiar with ICH-GCP and local authorities’ relevant regulations of medical device clinical study, experienced in quality management, able to comprehensively audit the clinical trial, and is actively providing high-quality audit service for clients. Our range of services includes: 1. On-site audits for medical device clinical trials and in vitro diagnostic product clinical trials study sites, as well as office audits for study documents (TMF). 2. System audits and third-party supplier audits of such as SMO (Site Management Organization) and central laboratories. 3. Preparations and support for sponsor and NMPA inspections. 4. Establishment of GCP full life cycle quality management system (QMS) for sponsors. 5. Registration of medical device clinical trial institutions.

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Computerized Digital Systems

We continuously and actively explore digital and innovative business models and make forward-looking arrangements. We can provide the following digital systems to our customers: 1. EDC – Electronic Data Capture System 2. IWRS – Interactive Web Response System 3. CTRM – Clinical Trial Remote Monitoring System 4. ePRO – Electronic Patient Reported Outcome System 5. eSafety – Pharmacovigilance system 6. CTMS – Clinical Trial Management System 7. eTMF – Electronic Trial Master File System

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Data Management and Statistical Analysis

Our DMSA team is data sensitive, has a strong study design background, and is good at DMSA of drugs and devices. We have a number of international statistical professionals. The team maintains a low turnover rate and high growth trend. Our senior statisticians have work experience of nearly 10 years in this field on average. We are expert in providing medical and statistical support for device submissions in the United States, Europe, China and other countries and regions, and have extensive experience with hundreds of projects. Our Aata team holds the following data management authorization certificates: 1. The only CRO company authorized by MediData Rave® in China 2. The first company in Asia which signed the CRO advantage projects with Oracle 3. Hold 10 Oracle certificates 4. Other certificates such as WHO-DD and MedDRA Our main data management systems include: 1. Oracle Clinical & Oracle Remote Data Capture 2. MediData Rave 3. InForm 4. ClinstReport 5. Clinflash Our main data management services include: 1. Data management consulting and training 2. Paper and EDC project 3. Case report form design 4. Build and validate database 5. Develop data management plan 6. Develop data validation plan 7. Edit check programming and testing 8. Double data entry and check 9. Electronization of data and manual review 10. Resolution of data queries 11. Medical coding 12. SAE reconciliation 13. Processing of external data 14. Database quality control 15. Blinded data review 16. Database lock 17. Data extraction and transfer 18. Preparation of data management report The range of biometric services we provide: 1. Offer comments to the Chinese Biostatistics Society as an expert, and participate in data standard setting, quality and biostatistics related projects of NMPA 2. Clinical trial design and consulting 3. Provide statistical support for the study protocol 4. Calculate the sample size / power 5. Randomizing design and coding 6. Develop statistical analysis plan 7. Prepare templates of statistical tables, figures and listings 8. Statistical programming 9. Generate data analysis set 10. Generate tables, figures and listings (TFLs) 11. Interim analysis and statistical support for the Data Monitoring Committee 12. Comprehensive summary and analysis of safety and efficacy 13. Statistical analysis report 14. Statistical support for the clinical study report 15. Statistical support for registration application 16. Statistical support for journals of various therapeutic fields, conference materials, posters and manuscripts

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Medical Monitoring

Our professional medical monitors can help the project team to better understand the objective, inclusion & exclusion criteria and process of the clinical trial, to provide medical support for the project team, and to ensure the safety of the subjects and the accuracy of the clinical trial data. The medical monitoring team will provide the following services for the client: 1. Draft / update the medical monitoring plan 2. Medical training (medical monitoring plan / protocol interpretation / knowledge of relevant disease areas) 3. Subject eligibility review 4. Regular medical monitoring meeting 5. Protocol violation / deviation review 6. Medical review for clinical data (adverse events, laboratory data, vital signs, medical history, and concomitant medication, etc.) 7. Medical consulting / Q&A Log maintenance 8. Review of clinical trial-related materials (clinical trial protocol, clinical summary report, and case report form, etc.) 9. Review of laboratory alert values 10. Data cleaning before database lock

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Safety Vigilance

With stable and high-quality team members, our safety vigilance and medical monitoring team can provide professional services needed by the client. We also have an intact and mature SOP system and rich experience in international project management. We offer the following services: 1. Review the study protocol; 2. Develop safety management plan 3. Review CRF and conduct relevant medical training 4. Collection, collation and classification of SAEs 5. SAE reconciliation 6. Preparation of SAE reports and submission to relevant regulatory authorities and sponsors 7. Support safety review committees (SRC) and independent data monitoring committees (IDMC) 8. Periodic safety reports 9. Clinical trial summary report review 10. Post-market risk analysis report and re-evaluation report

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Project Management

We have a senior project management team with years of expertise in various fields such as medical aesthetics, cardiovascular, ophthalmology, AI, surgical robots, and oncology. We have built thorough analysis of the current situation and future developments in these fields. Relying on a strong medical team and years of solid cooperation with the study sites, we have accumulated unique advantages and rich experiences in the project management for innovative devices. Tigermed-Jyton is customer-oriented and adopts a project management model where the project manager serves as a one-stop contact point for the sponsors, assisting them in coordinating other functional teams to improve communication efficiencies. The project manager regularly analyzes the deviations between plans and actual progress, as well as manages and prevents risks, ensuring that the project proceeds as scheduled. 1. Preparation of project plan 2. Clinical trial risk management 3. Clinical trial document management 4. Clinical trial financial management 5. Clinical trial meeting organization 6. Project training 7. Relevant supplier management

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Clinical Monitoring

We have a monitoring team with more than 200 CRAs in China, and more than 800 CRAs globally. We can provide local clinical monitoring and site management services. We are familiar with the study site process, and provide more convenient support and more professional services for the study sites. Our services include: 1. Study site screening 2. Ethics Committee filing and approval 3. Study site clinical trial agreement negotiation 4. Study site initiation and close-out 5. Study site monitoring and management 6. Investigational product management

泰格捷通（北京）医药科技有限公司

Beijing Tigermed-Jyton Co., LTD. ——Medical Writing

The medical writing team consists of dozens of excellent medical experts, writing specialists and statisticians. Core members have an average industry experience of more than 10 years and academic background of leading medical schools globally. Our innovative protocol design concept, scientific and rigorous work style, rich medical writing experience and effective SOPs have won the team a good reputation in the industry. Our service content includes the following: 1. Design of clinical trial protocols for medical devices / different phases of clinical trial protocols or unconventional study protocols for drugs 2. Preparation of clinical protocol related documents (e.g., case report forms, informed consent forms, and investigator’s brochure) 3. Preparation of clinical study report 4. Publishing papers on core journals 5. Preparation of medical materials for clinicians (e.g., questionnaire on updating treatment guidelines)

泰格捷通（北京）医药科技有限公司

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中国企业出海新动向

当今世界进入新的动荡变革期，经济全球化虽遇逆流，但新一轮科技革命与产业变革为中国企业走向全球开辟了新的空间。从产品出海到产能、品牌、供应链与生态出海，中国企业的国际化已由“可选项”成为“必答题”。有鉴于此，瓴德全球与华东政法大学互联网法治研究院共同发起编写本报告。出海不是一次性的决策，而是一场需要不断校准方向的长期航行。本报告基于瓴德全球的实务经验和华东政法大学的学术优势，把镜头对准中国企业出海的新动向与新变量——去哪里、以什么方式去、在什么规则下去，希望企业在启程之前即能识势、辨势，在市场、路径、合规与资本安排上顺势而为，少走弯路，行稳致远。

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A Director's Perspective: Exposure, Risks and Personal Liability

In this article, Mark Lee Chambers Law Corporation explores the fundamental paradox facing corporate leaders: while the company itself operates under the shield of limited liability, directors remain exposed to direct personal liability when breaching their duties.