One-stop Service for Medical Device IVD Landing in the U.S.

1. Requirements Description

Seeking medical and health companies or projects with intentions to expand overseas. Interested parties are welcome to communicate.

2. Company Profile

Jaryeefine Consulting is a professional consulting firm focused on the cross-border healthcare sector between China and the U.S., under the Jaryeefine Holding platform. We are dedicated to helping China's pharmaceuticals, diagnostics, medical devices, and digital health companies efficiently enter the U.S. market, covering registration strategy design, review document preparation, FDA communication support, and commercial integration.

Our Services:

1. FDA Registration and Digital Health Compliance Consulting: We cover all FDA review centers (CDRH, CBER, CDER, OPEQ) and provide registration pathway planning (e.g., 510(k) pre-market approval, De Novo, BLA, NDA, etc.), Q-sub/Pre-Sub preparation, technical document writing (CMC, UDI, algorithm validation, labeling, etc.), and full-process interaction support with the FDA for in vitro diagnostics, medical devices, pharmaceuticals, biologics, and AI/software products.

2. Sino-US Regulations and Localization Support: Assistance in establishing a U.S. company, tax planning, label conversion, cold chain logistics, sample pathways, etc.

3. Market Landing and BD Strategy: MVP Commercial Path Design, Exhibition, Channel, Financing, and License Support.

Our Advantages:

Former FDA Expert Team (13 members, with over 170 years of cumulative experience)

Bilingual and Bicultural + Full-process Adaptation for US-China Review

Own platform resources (registration, testing, logistics, etc.)

Equity Cooperation Mechanism (SAFE, SPV, License-Split)