Paper Submissions Module (PPM)
While eCTD is the way forward, majority of the developed and developing nations still support paper submissions as opposed to electronic submissions until they are equipped to fully accommodate electronic submissions.
PharmaReady Paper Publishing Module (PPM) is a latest addition to the regulatory submission suite of products. The paper publishing module is a complete web based application. This tool helps pharmaceutical companies in creating a paper submission via an array of simple to use screens. The final output is a portable document format (PDF) file that can be printed and submitted to the appropriate regulatory body. The module also helps one to save the output in a CD and submit it as NEES (Non eCTD Electronic Submission) submission, which still is a widely accepted form of submission for many EU countries.
PPM aids pharmaceutical companies who need to submit drug approval applications to regulatory bodies in a non electronic format. Once submitted the same can be stored as template for the particular nation and can be reused as and when required, reducing the challenge of recreating the same.
The application also brings lot of visibility to the organization on the submission that they are working by easing the process of review and saving large amount of wasted printed papers, thereby reducing the organization overheads and valuable time. So, PPM can be used to create submission similar to any eCTD submission and the output of the whole submission will be compiled as one PDF file per volume. This can later be printed out and submitted to the regulatory body of the appropriate country.
The key features of Paper Publishing Module are as follows:
- 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
- Accept all common Microsoft Office document formats as well as PDF
- Create agency-specific submission structure and compile documents
- Create agency-specific submission structure and compile docs
- 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
- Paper or electronic, create it once, submit it many times
The advantages of Paper Publishing Module are as follows:
- Streamlines the complex process involved in preparing paper based dossiers for submissions to non regulated markets
- A good start to migrate towards the paper less electronic submissions in near future
- Ease of implementation and use. Requires minimum start up time
- Highly cost effective solution
- eCTD submissions prepared using any software with valid .xml backbone can be imported in to PPM
