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Biomedical Devices

FDA Regulatory Submission (registration and Listing, 510k, 513g, PMA, IDE et al)

Enable Biomedical Devices for U.S. Medical Insurer Coverage, reimbursement and payment

Establish Quality System

Orthopedic implants

Biological assays

Drug delivery systems

Specific Biomedical devices

Design, research and development of biomedical device for U.S. marketing

Advanced Cellular and Gene Therapy

Process analysis and optimization, cell yield maximization, cell function, and high-throughput closed-system

GMP/GTP manufacturing: Cell selection, ex vivo expansion, activation, and transduction

Collaborate with U.S. clinical organizations

Regulatory compliance and consultation (FDA-CBER OCTGT, CDRH, AABB, AATB, FACT, NIH-RAC)

IND/IDE application and amendment


Product testing: Phenotype, viability, function, sterility

Stem cell-based therapy: Bone marrow, blood, umbilical cord blood stem and progenitor cells

Lymphocyte therapy

Mesenchymal stem cells

Multipotent adult stem cells

Immunotherapy and tumor vaccine

Dendritic cells, NK cells, lymphocytes


Commercial collaboration


Academic collaboration

others (please specify)

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