Your Bridge to the U.S. Healthcare Market
Jaryeefine Consulting Service is the regulatory and market entry arm of Jaryeefine, focused on helping innovative Chinese life science companies succeed in the United States. We provide not only FDA strategy and submission execution, but also end-to-end support for commercialization and channel establishment.
Our consulting division is powered by a cross-disciplinary team of former FDA officials, industry consultants, and operational executives with deep expertise across medical devices, diagnostics, digital health, biologics, and pharmaceuticals.
We support your journey across two critical dimensions:
Regulatory Excellence
- FDA submissions: 510(k), PMA, De Novo, IND, NDA, BLA, EUA
- Q-submission drafting and FDA meeting management
- AI/ML and SaMD pathway strategy
- Clinical trial design and U.S. site engagement
- Labeling, UDI, registration, and establishment setup
Market Access & Entry
Unlike traditional consultants, we go beyond paperwork. As part of the Jaryeefine holding company, we unlock tangible commercial pathways by helping you:
- Build distribution and sales networks in the U.S.
- Identify and negotiate with channel partners, group purchasing organizations (GPOs), and key opinion leaders (KOLs)
- Establish warehousing, logistics, and cold chain operations
- Navigate insurance coding, reimbursement strategy, and billing systems
- Localize branding, product messaging, and compliance with U.S. marketing rules
- Coordinate e-commerce or retail launch via platforms such as Amazon, Walmart, or CVS
Our integrated service model combines strategic clarity with operational execution—helping you go from product to presence in the U.S. healthcare system.
🌎 What You Need to Enter the U.S. Market
For International pharmaceutical, diagnostic, medical device, and digital health companies, entering the U.S. market involves more than product innovation—it requires regulatory strategy, operational compliance, and business localization.
Key Market Entry Requirements:
- Determining FDA regulatory pathway (510(k), PMA, EUA, BLA, ANDA)
- Setting up a U.S. legal entity (LLC or C-Corp), banking & tax advisory
- Product labeling, packaging, and documentation aligned with U.S. standards
- Cold chain logistics and import compliance (USP <1079>)
- Sample testing, MVP-level pilot launch, and channel integration
- English investor deck, BD strategy, and licensing preparation
- Post-approval lifecycle management and team localization
👥 Who We Are
FDA-Centric. Cross-Border Strategy. Built for Execution.
We are the regulatory and market-facing advisory arm of a cross-border healthcare holding group. Our consulting practice is led by a former IQVIA U.S. team leader, with extensive experience bridging regulatory strategy, clinical development, and go-to-market execution.
Our core team includes six former FDA reviewers and scientific officers, spanning all major regulatory centers. Collectively, we bring nearly a 100 years of FDA experience, and a deep understanding of both U.S. regulatory frameworks and commercialization pathways.
What sets us apart is not only our insight—but also our execution capacity. We operate alongside a growing ecosystem of operational entities under the Jaryeefine platform, enabling seamless integration between strategy and delivery.
Our Distinct Advantages:
- Full coverage of FDA review centers: CDRH, CBER, CDER, ODH
- Proven expertise across devices, diagnostics, drugs, biologics, and digital health
- Bilingual & bicultural approach tailored to Chinese innovators and their global investors
- Deep alignment with investor expectations, clinical requirements, and U.S. launch timelines
- Access to operational resources across Jaryeefine’s subsidiary network: regulatory, manufacturing, diagnostics, and distribution
We don’t just advise. We partner.
From regulatory planning to commercial traction, we enable international life science ventures to succeed in the U.S. market—decisively and compliantly.