Market Access
Global Expansion
Innovation knows no borders.
We help Chinese healthcare innovators expand into global markets while enabling international partners to access China’s healthcare ecosystem, creating broader opportunities for innovation.
Regulatory Affairs
Regulatory affairs serve as the core compliance guarantee for the launch and implementation of pharmaceutical and medical device products, running through the entire life cycle of product R&D, clinical application, marketing approval and post-marketing supervision. In accordance with the standards of NMPA, National Health Commission, drug regulatory authorities and international drug supervision systems, we provide professional regulatory consultation, compliance guidance, risk prediction and policy adaptation services for medical enterprises.
We accurately match the segmented regulatory rules for innovative drugs, generic drugs, modified new drugs and various medical devices, assist enterprises in sorting out R&D compliance paths, investigating R&D and production compliance risks, docking regulatory inquiries, and completing post-marketing compliance maintenance. It effectively avoids problems such as delayed launch, rectification and punishment caused by deviated regulatory understanding, non-compliant processes and lagging policy adaptation, and builds a solid compliance foundation for product commercialization, investment and financing transactions, and industrial M&A.
Registration
Registration is a key link for medical products to obtain marketing qualifications and achieve legal market circulation, covering domestic registration and cross-border declaration of all categories of medical products including pharmaceuticals, medical devices and in vitro diagnostic reagents. We provide one-stop full-process registration services including data sorting, template optimization, data verification, system inspection, application submission, supplement reply and approval follow-up, adapting to special approval channels such as priority review, conditional approval, breakthrough therapy and emergency approval for innovative products.
Pricing
Pricing strategy is the core system for the commercial profitability and market competition of medical products. Combining product clinical value, technical barriers, competitor pattern, cost structure, industrial policies, centralized procurement rules and market supply and demand, we provide scientific and compliant pricing solutions for innovative drugs, generic drugs, medical devices and IVD reagents.
Clinical Trials
Clinical trials are the core key link for new drugs from R&D to marketing, including Phase I, II, III clinical trials and post-marketing Phase IV clinical studies. They serve as the core basis for verifying the safety, effectiveness and tolerability of drugs, as well as a key indicator for medical investment project value judgment.
National & Provincial Reimbursement Catalog Inclusion
We focus on national and provincial medical insurance catalog inclusion application services for innovative drugs, modified new drugs, high-end medical devices and IVD diagnostic products, covering full-scenario businesses such as annual regular medical insurance admission, dynamic adjustment and new category application.
Medical Insurance Negotiation & Payment Standard Verification
Focusing on the core links of medical insurance access, we provide professional medical insurance price negotiation, renewal negotiation, payment standard calculation and verification services.
Medical Insurance Implementation & Commercial Empowerment
Focusing on the terminal implementation and long-term operation of products after medical insurance access, we provide services including medical insurance policy implementation adaptation, compliant promotion of terminal channels, patient payment empowerment and product market volume optimization.
Policy & Guidelines
Policy & Guidelines services focus on the strong supervision characteristics of the medical industry, providing real-time interpretation of national and provincial regulatory policies, industry guidelines, approval rules and industrial specifications in the fields of pharmaceuticals, medical devices, IVD and medical services. It covers a full-dimensional policy system including new regulations on drug and device registration, centralized procurement policies, medical insurance access rules, clinical research guidelines, quality control standards, cross-border medical access policies and industry compliance rectification requirements.