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Proven guidance and implementation!

Biologic products include, Allergenics, Blood & Blood Products, Cellular & Gene Therapy Products, Tissue & Tissue Products, Vaccines, Xenotransplantation, and Fecal Microbiota Products. Elexes offers the following end-to-end solutions for companies developing such products.


What we offer


Companies partner with us to seek approval and meet the extensive requirements in the Code of Federal Regulations (CFR) and other applicable regulations


A robust quality system goes a long way in producing safe and effective products. We assist in developing integrated quality systems per applicable requirements.


We help you identify and consolidate all the product documents needed for getting a regulatory approval based on the target country’s specific requirements.


To conduct a clinical trial you need numerous documentation and clinical trial applications to be filed with a regulatory body. We can support you with:

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