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Easily generate high quality eCTD and ICH compliant output for any region
During the entire lifecycle of their products, Life Sciences organisations (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, detailed bookmarking & hyperlinking, 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 organisation’s submission approval process.
With DocShifter, local regulatory requirements are easily captured in workflows. These generate consistent, high-quality output in a cost efficient way while reducing the risk for human errors.