We build the best path link to future medical

We are leaders in regulatory affairs for biomedical device, and advanced cellular & gene therapy.


We provide the most professional consulting services to Chinese biomedical device manufacturer, pharmaceutical industries and biotechnology companies. We have excellent, long-standing working relationships with FDA and other regulatory bodies ensuring that your submissions are fairly reviewed and your quality systems are properly prepared.


We offer a high-integrity approach to the most daunting challenges for pharmaceutical industries, medical device manufacture and cellular therapy developers.


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U.S. FDA Regulatory Submission, U.S. Medical Insurance Coverage of Durable Medical Equipment (DME)

U.S. is the most important market for exportation of related medical devices and products. These devices need to obtain U.S. FDA “approval” in order to enter U.S. market. The U.S. FDA has established risk-based classification of medical devices. Each types of devices are assigned to one of the three regulatory classes (Class I, II and III) based on the level of control necessary to assure the safety and effectiveness of the device. We, the U.S. Elliot Medical Solutions LLC, are the professional partner you can trust. We provide professional services to help Foreign medical device manufacturers to establish quality system, improve R&D, conduct regulatory submissions and obtain FDA’s “approval”. Even more, we help our customers to pass the hurdles of U.S. medical insurer coverage, reimbursement and payment ensuring successful product distribution in U.S.



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Translate Innovative Cellular & Gene Therapeutics from “Bench” to “Bedside”

Our team of Advanced Cellular and Gene Therapy has senior experts who specialize in regulatory policies, IND/IDE application, GMP/GTP manufacturing, cellular and gene product testing (cell selection, ex vivo expansion, activation and transduction), process analysis and optimization. We provide high-integrity approaches and highly reliable solutions for pharmaceutical industries or biotechnology companies to translate their cellular and gene therapeutic products from “bench” to “bedside”.


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Partners

We work side-by-side with industry experts to amplify our collective impact and increase our probability of success.

Entrust professional consultants for FDA registration and “approval” will expedite the regulatory submission, reduce cost and avoid penalty.

Entrust professional consultants to help to pass hurdle of medical insurer coverage, significance of which for marketing biomedical devices in U.S. cannot be overstated.

Entrust professional consultants to build extensive collaboration with U.S. clinical centers will help you to optimize manufacturing process, reduce time and cost, thereby, to gain access to capital markets.

We believe that substantial progress on the toughest problems in healthcare industries will require deep collaboration with partners who understand current challenges and are willing to look at a problem differently.

We are always open to any type of collaboration with academic schools, institutes and organizations.

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