The Tongfang Pharmaceutical, Healthcare, and Legal Service Center is a specialized legal service platform that focuses intensively on the entire pharmaceutical, medical, and greater health industry chain. The center is staffed by multidisciplinary lawyers who hold qualifications in medicine, pharmacy, and law. These lawyers not only possess clinical practice experience spanning internal medicine, surgery, and orthopedics, as well as practical expertise in pharmaceutical compliance, but also excel at providing comprehensive legal support to healthcare institutions—from handling medical disputes and managing medical quality and safety to conducting compliance reviews of medical records and implementing risk controls for major decision-making. Additionally, they have extensive hands-on legal experience in areas such as drug lifecycle compliance, intellectual property protection, and commercialization.
The center is committed to providing tailored legal services to various stakeholders within the broader “medical care, pharmaceuticals, wellness, nutrition, and tourism” health industry ecosystem: offering comprehensive solutions—including medical quality and safety, physician-patient disputes, data compliance, and investment & M&A—specifically for public and private hospitals, clinics, and physical examination centers; providing end-to-end compliance support—from preclinical research and clinical trials (GCP) through registration filing, manufacturing (GMP), and distribution (GSP)—to innovative drug and generic drug companies; and delivering specialized guidance on product registration and filing, advertising compliance, and business model risk management to companies involved in healthy foods, dietary supplements, medical devices, medical aesthetics, and internet-based healthcare platforms.
As your trusted legal partner in the industry, we adopt a unique perspective—“understanding medicine, understanding pharmaceuticals, and understanding the law”—to gain a deep insight into your business logic and regulatory environment. Our goal is to provide robust support for your strategic decision-making and daily operations, working together to build a pharmaceutical and healthcare ecosystem that is more professional, safer, and brimming with innovative vitality.
II. Business Type/Service Content/Scope
Institutional and Personnel Qualification Compliance
Institutional Practice Licensing (handling from start to finish the establishment, modification, and cancellation of practice licenses), Technical Application Filing (assisting in completing clinical application filings for new technologies such as interventional therapy and stem cell therapy), and Personnel Qualification Management (providing review and risk-control support for healthcare professionals’ practice qualifications).
Compliance with Core Medical Practices
Medical Documentation Standards (providing guidance on medical record writing standards, as well as customization and revision of core documents such as surgical consent forms and informed consent forms for special examinations/treatments), Quality and Safety Management (assisting in the establishment of medical error prevention procedures and internal quality management systems), Criminal Risk Prevention (specialized guidance to help avoid criminal legal risks such as medical malpractice offenses), and Logistics Compliance Support (offering comprehensive compliance solutions for the entire process of medical waste management and wastewater treatment).
Compliance in the use of medical insurance funds
Guidance on Fund Usage (providing guidance on the proper use of medical insurance funds and helping to avoid violations such as "phantom hospital stays" and "fictitious billing"); Reimbursement Catalog Consultation (offering expert advice on which medications and medical services are covered by the medical insurance catalog); Agreement Review (conducting professional reviews of the terms and conditions of agreements signed with medical insurance administration authorities).
Conduct clinical trial compliance
Provide compliance training for physicians and research personnel involved in clinical trials (e.g., GCP practical operations, boundaries for protecting subject rights, data recording standards); assist in addressing professional risks arising from trial-related activities (e.g., medical disputes, regulatory accountability). Assist hospitals and other research institutions in developing internal compliance management systems for clinical trials, thereby enhancing their qualifications to undertake clinical studies. Offer mediation, negotiation, and litigation/arbitration support for disputes between researchers and sponsors (e.g., fee settlements, liability determinations) as well as disputes between researchers and subjects (e.g., informed consent controversies, adverse event compensation), safeguarding the legitimate rights and interests of both research institutions and researchers.
Responding to and Handling Medical-Patient Disputes
Diversified Mediation (acting as an agent in mediating medical-patient disputes and striving to resolve conflicts before litigation), Expert Appraisal and Litigation (deeply involved in technical appraisals of medical accidents and providing professional agency services for medical-patient dispute litigation).
R&D and Regulatory Compliance
Clinical Trial Compliance (Comprehensive compliance review covering the entire clinical trial lifecycle, including ensuring compliance in protocol design and investigator’s manual preparation; reviewing the legal and ethical compliance of informed consent forms and case report forms (CRFs); preventing disputes over subject rights and interests; preparing compliant response documents for regulatory inquiries and on-site inspections during clinical trials; assisting in rectifying non-compliant items to reduce the risk of inspection failures; drafting and reviewing agreements with collaborators such as investigators (hospitals), SMO companies, and testing institutions to clearly define the compliance responsibilities of each party and avoid legal risks arising from agreement loopholes; providing compliance solutions for unexpected situations during clinical trials, such as serious adverse events (SAEs) involving subjects, suspicions of data falsification, and ethical controversies; assisting in conducting risk assessments and developing appropriate responses to mitigate corporate legal liabilities and brand damage; and planning registration pathways (providing strategic advice and application support for special registration procedures such as breakthrough therapy designation, conditional approval, and priority review).
Production and Quality Compliance
GMP Compliance System (providing comprehensive GMP certification support, conducting compliance reviews for changes in production processes, and ensuring that production activities meet quality management standards); Quality Risk Management (assisting in the establishment of a pharmaceutical production quality control system, designing procedures for recalling nonconforming products, and providing quality crisis response plans).
Operations and Distribution Compliance
Compliance in the distribution channel (compliance review of pharmaceutical procurement, storage, transportation, sales, and other distribution activities to ensure adherence to regulations governing pharmaceutical distribution management); compliance in business operations (compliance guidance on pharmaceutical promotion, advertising, investment cooperation, and other business activities, and assistance in establishing a quality traceability system for the distribution channel).
Intellectual Property Protection
Patent Portfolio and Filing (representing core patent applications for innovative pharmaceutical compounds, uses, and other key inventions), Infringement Risk Prevention and Control (conducting competitive product patent analysis to identify and mitigate both infringement and being-infringed risks), and Trade Secret Protection (perfecting confidentiality agreements and internal policies, establishing a tracking mechanism for intellectual property rights of departing employees, and safeguarding core technological assets).
Full-Cycle Compliance Management for Health Products
Health food compliance (providing end-to-end guidance and agency services for “registration” and “filing” of health foods); advertising and promotion review (rigorously examining the content of health food advertisements to ensure legal and compliant promotion and to avoid legal risks such as “exaggerated efficacy”); medical device market access (offering comprehensive support for the registration, filing, and application for manufacturing licenses of Class I, II, and III medical devices, thereby facilitating product launch pathways).
Compliance-Based Construction of New Business Models in Health Services
Compliance for medical aesthetic institutions (assisting in the filing of medical beauty projects, reviewing physician qualifications, and ensuring that institutional operations comply with regulatory requirements); compliance for internet-based healthcare services (providing compliance solutions for emerging models such as telemedicine and online consultations, with a particular focus on standardizing key aspects like prescription management and electronic medical records); and compliance for health management companies (conducting legal reviews of the content of health consultation services, clarifying service boundaries, and mitigating operational risks).
Medical Dispute Resolution
Preemptive Rights Protection and Evidence Organization (providing comprehensive consultation on rights protection throughout the entire medical treatment process; medical-background lawyers meticulously review medical records and examination reports, guide the proper preservation of key evidence, and help mitigate the risk of evidence loss); Preliminary Determination of Fault and Liability (lawyers with experience working in Grade III hospitals and medical experts in relevant fields conduct a comprehensive review of medical records and related materials, drawing on clinical practice guidelines and other authoritative sources to preliminarily analyze whether the medical institution was at fault, the causal link between the fault and the resulting harm, and to estimate the proportion of liability, thereby providing professional guidance for pursuing rights protection); Multi-Channel Dispute Resolution Representation (representing patients in negotiations and consultations with medical institutions and parties liable for medical products; participating in people’s mediation and administrative mediation of medical disputes; for cases where negotiations fail, providing full-service representation through litigation or arbitration to maximize the protection of patients’ rights); Specialized Support for Forensic Appraisals (precisely matching patients with reputable forensic appraisal institutions, assisting in the organization of appraisal materials and clarifying key appraisal issues; lawyers with medical backgrounds provide end-to-end monitoring of the appraisal process, offering expert support on core appraisal matters such as the reasonableness of medical treatments and the degree of disability, thereby enhancing the fairness and favorable outcomes of appraisal results); Claim Preparation and Enforcement (assisting in calculating all compensation items—including medical expenses, lost wages, disability compensation, and compensation for mental distress—and developing the optimal claim strategy; representing patients in compensation negotiations and in enforcing court judgments and mediation agreements to ensure that patients’ legitimate rights and interests are fully realized).
Clinical Trial Risk Prevention and Management
Provide compliance counseling to subjects participating in clinical trials (e.g., interpreting the terms of the informed consent form and confirming the boundaries of their own rights and interests). In cases where subjects’ rights and interests have been violated (e.g., insufficient informed consent or inadequate handling of adverse events), assist in connecting subjects with research institutions and sponsors to assert their rights and provide legal support.
Provided legal advisory services to multiple institutions, including the First Affiliated Hospital of a certain medical university, the Second Affiliated Hospital of the same medical university, a certain orthopedic hospital in Huludao, and a hospital in Suizhong County, offering them comprehensive legal support to ensure compliant operations and stable development of medical institutions through professional services.
Responsible for compliance work related to clinical trials at a large Grade-III hospital and several other medical institutions, providing comprehensive legal support throughout the conduct of clinical trials, safeguarding the rights and interests of research institutions and investigators, and protecting the rights and interests of trial participants.
Provided specialized legal services for the construction of a trade secret protection system for a pharmaceutical company, including identifying the scope of confidential information such as core technologies and formulations, revising confidentiality agreements for R&D personnel, designing an intellectual property tracking mechanism for departing employees, establishing a comprehensive, end-to-end confidentiality management system, and ensuring the effective implementation of the system.
Provided legal services for a medical device company and an investment firm regarding the transfer of patent rights and technological achievements, conducted technical due diligence, assessed asset value in combination with market prospects and technological innovation, developed customized transfer plans, drafted and reviewed specialized contracts governing ownership of rights and risk allocation, and assisted both parties in completing the asset transfer.
In the case of “Zhao Mouling v. Huludao Hui’er Orthopedic Hospital—Dispute over Liability for Medical Damage,” the hospital’s representative requested that the expert witness appear in court. Following a successful cross-examination, the court did not adopt the expert opinion unfavorable to me, and the case was ultimately resolved smoothly through mediation.
In the case of “Chen Mouying v. Suizhong Hui’er Orthopedic Hospital—Dispute over Liability for Medical Injury,” representing the hospital, we successfully applied to the procuratorial authorities for a protest and received their support, ultimately prompting a retrial and securing a revised judgment.
In the case of “Dispute over Medical Liability between Mr. Nan and a Certain University Hospital in China,” despite the patient’s failure to undergo an autopsy and the objective difficulties in presenting evidence, the attorney representing the patient, through professional argumentation, successfully persuaded the forensic appraisal authority to determine that the medical institution bore equal responsibility, thereby laying a favorable foundation for the first-instance trial and ensuring the conclusion of the first-instance proceedings.
In the case of “Duan v. the Affiliated Hospital of a Certain University in Dalian regarding medical malpractice liability,” the attorney representing the patient successfully identified the hospital’s primary liability through forensic medical appraisal, securing a decisive victory at the first-instance trial. Moreover, the hospital’s representative was prompted to offer an apology in court, thereby restoring the client’s dignity and obtaining compensation.
In the case of “Liu v. Qi, Weihai Central Hospital, and Others—Dispute over Medical Damage Liability,” this case involves the intersection of criminal and civil law, as well as concurrent liability for personal injury and medical damage, making the legal relationship highly complex. Representing the patient side, we secured a substantial compensation award for our client in the first instance through precise legal arguments. Subsequently, both the second-instance and retrial proceedings successfully upheld our client’s favorable verdict.
In the case of “Liu v. a Maternal and Child Health Hospital in Linzhou—Dispute over Medical Damage Liability,” the attorney representing the patient successfully obtained crucial, core evidence through meticulous investigation and evidence collection, thereby establishing a powerful deterrent that compelled the hospital to proactively request mediation. Ultimately, this led to an exceptionally favorable compensation settlement for the client.
In the case of “Yu v. the General Hospital of a Certain Military Region—Dispute over Medical Malpractice Liability,” I acted as counsel for the patient’s side. In this case, the patient died without an autopsy being performed, making it extremely difficult to determine liability. Through professional and strategic representation, the final expert opinion concluded that the medical institution bore “equal to primary responsibility,” and the compensation awarded far exceeded the client’s initial expectations.
In the case of “Li v. a certain hospital affiliated with Medical University—Dispute over Medical Malpractice Liability,” I acted as counsel for the patient. The patient’s medical condition was highly complex (with more than 20 diagnoses), and no autopsy was performed. As a result, the expert appraisal process nearly reached an impasse. Despite these significant challenges, I ultimately succeeded in overcoming numerous obstacles to complete the appraisal. During the first-instance trial, I meticulously cross-examined the expert witness, effectively exposing the hospital’s shortcomings and strengthening the judge’s conviction regarding the hospital’s negligence. Ultimately, the court ruled that the hospital was liable, and this decision was upheld on appeal.
In the case of “Li v. a certain hospital affiliated with Southern Medical University regarding a dispute over medical malpractice liability,” the attorney representing the patient cross-examined the expert witness in court regarding the expert opinion. Thanks to meticulous preparation before the trial and skillful questioning techniques during the hearing, the attorney successfully persuaded the judge to increase the compensation amount by an additional 15% on top of the originally determined equal share of responsibility, thereby securing an extra several hundred thousand yuan in compensation for the client.