While eCTD is required by some jurisdictions, and NeeS in others, there remains a large number of regulators where dossiers and variations to them must be submitted in paper.
Navitas pharmaREADY Paper Publishing Module (PPM) is the latest addition to the regulatory submission suite of products. The paper publishing module is a complete web based application. This tool enables Life Science companies to create a paper submission via a series of easy-to-use screens. The final output is a PDF file that can be printed and submitted to the appropriate regulatory body. Alternatively, in the event that a NeeS (Non eCTD Electronic Submission) is required as is the case in many EU countries, the module saves the output to a CD ready for delivery to the desired authorities.
Navitas pharmaREADY PPM is available as an independent product or is easily tightly integrated with other pharmaREADY products including pharmaREADY DMS.
PPM Key Features:
- Import eCTD Submissions into PPM and manage the imported submission as any other paper submission
- Prepare submission documents once and submit the dossier across different global regulatory agencies without significant changes compared to duplicating the entire effort for every new agency
- Assemble & organize submission documents based on volumes, modules and agency-specific classifications
- Accepts all common Microsoft Office document formats as well as PDF
- Create agency-specific submission structure and compile documents
- Create volume and module headers and separators
- Create global & volume based table of contents
- Preview the print-ready documents to avoid last minute corrections
- Print final submission-ready dossier