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HCL Technologies

Submissions Processes made easy with Templates

Submissions Processes made easy with Templates

Several Pharmaceutical and biotech organizations across the globe are making the switch from paper to electronic format for submitting their marketing authorization applications to FDA and other regulated agencies in Europe, Japan, and Canada. The decision to adopt the electronic Common Technical Document (eCTD) submission format is a strategic one, offering the sponsor significant benefits. Most important step a regulatory submission writer can take towards preparing documents for a regulatory submission is to use a submission-compliant template to create each document. This white paper provides insights on how the pain points in adopting commercially available eCTD can be effectively addressed by creating geo specific templates which would save cost and time for Pharma companies.


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