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Category A : Conversion to eCTD. |
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Given the CTD section-wise data in the form of PDF or any other format as per eCTD guidelines, Educe™ offer to |
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convert the data into eCTD format. |
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Review and Approval of the final eCTD to be done by the Client. |
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Educe™ guarantees the format of the eCTD (Technical Validation) and not the content. |
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This service can be provided at the Client site OR Educe™ office. |
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Category B : Conversion to CTD. |
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Given the non CTD complaint data in the form of word or PDF, Educe™ offer to convert the same data into CTD format. |
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Advice on the new requirement of data as per the CTD requirements which could vary from product to product. |
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Review and Approval of the final CTD content will be done by Client and Educe™. |
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Educe™ guarantees the conversion and completeness of the format into the CTD but will rely on the contents provided |
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by the Client. |
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Further Educe™ will convert the CTD data into eCTD format similar to Type 1 service mentioned above. |
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This service can be provided at the Client site OR Educe™ office. |
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Category C : SPL Conversion. |
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Given the labeling information for Package Insert either in Word or PDF, Educe™ will convert it into the SPL standard |
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format as mandated by USFDA. |
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Two or three rounds of iterations could be done for final changes by the Client. |
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Once finalized, the SPL cut into the CD or through any media will be sent to the Client. |
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Same process will be applicable for SPL with PLR format. |
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Standard points for the service models: |
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Educe™ signs CDA for the said service. |
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Authenticity of the contents whether in CTD or non-CTD format is Client’s responsibility. |
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Educe™ guarantees the CTD or eCTD format as a part of the service contract. |
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