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Is generating high quality eCTD and ICH compliant output too complex?
During the entire lifecycle of their products, Life Sciences organizations (Pharmaceutical, Medical Device and Biotechnology, Animal Health etc.) generate huge quantities of documents. These need to be provided to the individual health authorities around the globe where the products are marketed.
There are specific local requirements for the formats that this information must be provided in, including the file type and the technical specifications (PDF version from 1.4 to 1.7, detailed bookmarking & hyperlinking, optimization, headers and footers, web optimization, image optimization etc.) for that format.
Manual conversion of documents to meet these requirements is time-consuming, cost ineffective and leads to inconsistent final content. This introduces a potential risk to the organization’s submission approval process.
DocShifter converts all your original documents to submission ready PDF files. These PDF files (renditions) meet the regulatory requirements of any health authority, for any type of submission (MAA/NDA, CTA/IND etc.). Generating consistent, high-quality output in a cost-efficient way while reducing the risk for human errors. Easy, fast, automated.