The U.S. based clinical-stage Company is into developing novel immunotherapies for treatment of various types of cancers and other autoimmune disorders, requested Freyr to develop IND (Investigational New Drug) templates to comply the Regulatory mandate for submission of commercial INDs in eCTD format. Freyr developed full-fledged IND templates that can be used for submission of all phases of INDs (Ph-I, Ph-II and Ph-III) for both pharmaceutical products and biological products.
Read the case to go through various solutions Freyr offered to the client while developing the templates.
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