Biomedical Device

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.

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Biomedical Device

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


Gene Therapy
--- Stem cells, lymphocytes


Tissue-specific Cell Therapy
--- Islet cells, hepatocytes, neural cells, chondrocytes, dermal cells


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Advanced Cellular &Gene Therapy

Health Insurance and Medicare Options

Access to the American Medical Insurance Company's list of suppliers is self-evident that this will allow your products to enter the nationwide chain of pharmacies and as a choice for hospital doctors to open a huge market for you.




 

 
 

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Health Insurance and Medicare Options

Clinical Trials Collaborative

Assist the United State clinical trial sites to ensure quality and increase success rates for biopharma companies and CROs
 
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 Clinical Trials Collaborative
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