Our Team

Mr.Peng has 20 years of practical experience in the pharmaceutical field. He has held managerial positions in Chinese and overseas companies in biomedical R&D and production, pharmaceutical product investment management, medical device registration, and clinical trials of drugs and medical devices. Having worked in pre-clinical and clinical CRO for many years, he is experienced in medical product transformation as well as clinical trial management and registration of medical devices in China. He covers all of China and the global business of medical devices and drugs. He earned a Master of biochemistry from East China Normal University and EMBA and is a licensed pharmacist. He is a standing member of the Digital Therapy Professional Committee of the China Association of Rehabilitation Technology Transformation and Promotion Association, a specially invited expert of the Clinical Trial Branch of the China Association for Medical Devices Industry, a member of the Technical Committee of the Shanghai Biomedical Testing Reagent Engineering Technology Research Center, Shanghai Rehabilitation Assistive Devices and Elderly Welfare Industry Technology Innovation Strategic Alliance Director and member of the Medical Devices Committee of the China Association for the Promotion of Pharmaceutical Products.

Mr. Shan has 15+ years of experience in this industry. As a senior statistician, Mr. Shan has participated in hundreds of projects in clinical trial design, data management and statistical analysis of medical devices and drugs. He is familiar with relevant laws and regulations and is insightful in clinical risk control. He graduated from Academy of Military Medical Sciences as a Master of Epidemiology and Biostatistics and a Doctor of Military Preventive Medicine.

Ms. Li has 15+ years of experience in medical device registration. Ms. Li is responsible for registration and regulatory affairs of medical devices in various segments in China and overseas, overseeing more than 5000 registration projects. As an expert in regulatory affairs, Ms. Li can assist startups in establishing a team’s regulatory compliance awareness, provide consulting service covering whole chain of regulatory affair logic for companies with innovative products, and provide modular services in complex market environments. 

Mr. Wan is an expert in medical device regulations and Good Manufacturing Practice (GMP). Mr. Wan has been engaged in medical device supervision for more than ten years in the Medical Device Division of Beijing Medical Products Administration. He has participated in discussions several times to revise regulations organized by the National Medical Products Administration. He has participated in the drafting and revising of Beijing medical device supervision and administration regulations, and  organized the compilation of supervisory inspector manual for the Beijing medical device manufacturers. 

Ms. Zhang is responsible for the registration and clinical trial of IVD products in China and overseas. She has nearly 20 years of experience in the IVD industry. With years of experience in the IVD industry, she has previously worked in multinational corporations such as Danaher and Siemens, engaged in management of IVD product development, clinical affairs, regulatory affairs and quality system. During the period, she also completed the "National 863 Program of the 11th Five-Year Plan" as a core member.

Ms. Chen, as a Master of Medicine, has six years of experience in design and clinical evaluation of medical device clinical trials, covering orthopedics, ophthalmology, cardiovascular, medical cosmetology, oncology, respiratory and other fields. She has participated in the review and writing of more than 200 medical device protocols and clinical evaluation projects.

Ms. Wang has more than a decade of experience in clinical study. She is mainly responsible for the expansion and clinical operation management in oncology and medical cosmetology. Participated in and guided clinical trials for registration, including tumor electric field therapy instrument, ultrasonic scalpel, radiotherapy equipment and other products in the field of oncology as well as photoelectric, hyaluronic acid, botulinum toxin, polylactic acid and other medical cosmetology products.

Ms. Sun has more than 15 years of industry experience. She is responsible for supervising and maintaining the operation of Tigermed-Jyton’s quality assurance system, as well as institution co-establishment and training. She has worked in the fields of pharmaceutical registration, clinical operation of medical devices and IVD and quality management of medical devices and IVD. Ms. Sun is familiar with relevant regulations of medical devices, especially for quality risk management and control in clinical trials, good at enterprise process sorting, and familiar with the construction of clinical trial management systems.

Ms. Yang has 15+ years of experience in medical device industry. She is responsible for establishing and maintaining overseas regulatory teams and coordinating overseas regulatory affairs, clinical research projects, MRCTs for medical devices, partial research in China directly managed by oversea sponsors, real-world studies of medical devices, and post-market or investigator-initiated studies. She has years of management experience in medical device regulatory affairs in multinational corporations and is experienced in overseas medical device registrations in 30+ countries and regions. 

Ms. Zhang is responsible for medical device business management, brand management, online marketing, and overseas business promotion. She has 10+ years of experience in business development and management, and marketing operations and promotion in CROs.

Ms.Xiao is responsible for China and Global business development services for medical device R&D and manufacturing enterprises, covering medical device R&D, pre-market and post-market stages. She has over 15 years of market expansion and management experience in the medical device industry.

graduated from Webster university, bang kok C'empus, lhailend with mlester degree in"usinas Administration; and a Rachalar af scienae, with majnr in Genatics fromchulalenakorn University, Theiland, leow has more than 18 years progressive.xcrirncc in all phase af Sals ard Markcting for glahal and dlomcsti husin.ssas. ln herprofessional caraer, weow has worked in diffarent countries such as Vietnam, Philippines.Manmar and (amhacis in diucrec industries for diffrrant campinir inrluding hach aamh, DsG Intamational, TNT Fxpress, Twin  atus, Align Technclogy and Nu Skin.

Ms. Tanushree Ghatak is based out of Mumbai with 17+ years’ experience in medical device industry and a B.Tech in Biochemical Engineering. She is responsible to maintain client relationship by ensuring appropriate strategies in place, managing license holding for overseas manufacturer and ensuring on-time submission of product registrations, renewals and variations thereby ensuring business continuity and maintaining compliance.

In her previous assignments, Tanushree has led Regulatory Affairs, Quality Assurance in several multi-national corporations like Cordis, Cardinal Health, Johnson & Johnson, Medtronic. She has been instrumental in setting up Corporate Quality systems and has manufacturing experience working in Baxter. She is a Green Belt in Lean Six-Sigma and also a Lead Auditor of ISO 13485:2016 standards.