U.S. FDA Regulatory Submission--510(k), 513(g), Pre-IDEs, PMA and IDEs; FDA Establishment registration and product listings; Import/Export requirements, FDA certificate to Foreign Government (CCFG); Official correspondent and U.S. agent to the FDA.
Clinical Trials --Help you to manage your clinical trials
Quality Systems Development--21 CFR 820，UDI，ISO 13485
Durable Medical Equipment Enrollment by U.S. Medical InsurerHelp you to pass hurdles of U.S. medical insurer coverage, reimbursement and payment to effectively distribute your products in U.S.
Biomedical Device R&D Consulting Services – We specialize in various biomedical devices, orthopedic implants, biological assays, drug delivery systems, et al.more
Advanced Cellular &Gene Therapy
Area of Special Expertise
IND/IDE applications, amendments；Cell collection, storage and banking; GMP/GTP cell engineering; Cell selection; Ex vivo cell expansion, activation, and transduction; Product testing: phenotype, viability, function, sterility.
Stem Cell-based Therapy:
--- Bone marrow, blood, umbilical cord blood stem and progenitor cells.
--- Mesenchymal stem cells
--- Multipotent adult stem cells
--- Immunotherapy, tumor vaccines
--- Dendritic cells, NK cells, lymphocytes
--- Stem cells, lymphocytes
Tissue-specific Cell Therapy
--- Islet cells, hepatocytes, neural cells, chondrocytes, dermal cells
Health Insurance and Medicare Options
Clinical Trials Collaborative
- Total 1 Page 4 Records