eCTD, or Electronic Common Technical Document, is a standard format for the submission of regulatory documents in the pharmaceutical industry. With the rise of digital technologies, eCTD has become increasingly popular, and many companies are now looking for efficient and reliable eCTD software solutions. One such solution is SUBMIT PRO, a cloud-hosted eCTD software that offers a range of benefits for pharmaceutical companies. In this essay, we will explore the features and benefits of SUBMIT PRO under the following subheadings:
Introduction to SUBMIT PRO
SUBMIT PRO is a cloud-hosted eCTD software that enables pharmaceutical companies. To submit regulatory documents electronically to regulatory agencies around the world. The software is designed to be user-friendly and easy to navigate, making it ideal for companies that are new to eCTD submissions. it provides a comprehensive set of tools and features to support the entire submission process, from document preparation to submission tracking.
Features of SUBMIT PRO
SUBMIT PRO offers a range of features that enable pharmaceutical companies to prepare and submit regulatory documents in compliance with regulatory requirements. The software supports all major eCTD standards, including those required by the FDA, EMA, and Health Canada. Key features of it include document management, publishing, validation, and submission tracking.
Document management
Document management is a critical aspect of eCTD submissions, and it provides robust tools. Which manage all types of documents, including PDFs, Word documents, and multimedia files. The software supports version control, which enables users to track changes and collaborate on documents with ease. SUBMIT PRO also provides automated naming conventions and document organization. Which ensures that documents have storage and name correctly.
Publishing
SUBMIT PRO enables users to publish eCTD submissions in compliance with regulatory standards. The software supports the creation of bookmarks, hyperlinks, and cross-referencing, which enables users to create navigation aids that make it easier for reviewers to navigate through the submission. The software also provides automatic formatting, which ensures that the submission is present in the correct format.
Validation
Validation is a critical step in the eCTD submission process, and SUBMIT PRO provides advanced validation features to ensure that submissions are compliant with regulatory requirements. The software performs a range of checks, including those related to document formatting, file size, and content. it also provides a comprehensive validation report that identifies any issues or errors that need to be addressed before the submission is made.
Submission tracking
SUBMIT PRO provides advanced submission tracking features that enable users to monitor the progress of their submissions in real-time. The software provides status updates, notification alerts, and automatic reminders to ensure that submissions are made on time. It also provides comprehensive reporting, which enables users to track the performance of their submissions and identify areas for improvement.
Benefits of SUBMIT PRO
SUBMIT PRO offers a range of benefits for pharmaceutical companies that are looking to streamline their eCTD submission processes. The software is a cloud-host, which means that we can access it from anywhere with an internet connection. This makes it ideal for companies with multiple locations or remote teams. it also provides a range of collaboration tools, which enables teams to work together on documents and submissions. Additionally, it offers competitive pricing, which makes it an affordable option for companies of all sizes.
SUBMIT PRO Expertise
PRO Expertise can assist you with the entire submission process, from collaborative preparation and review to managing Health Authority queries. The system is flexible and can be easily integrate with popular eDMS solutions. We ensure that all user activities are validated effectively and automatically with electronic signatures, and we provide detailed reports on every step of the process. You can track your submission from start to finish, and we use automated global eCTD templates that comply with 21 CFR part 11 regulations.
In conclusion, SUBMIT PRO is a comprehensive and user-friendly cloud-hosted eCTD software. That offers a range of benefits for pharmaceutical companies. With advanced features for document management, publishing, validation, and submission tracking, it enables companies to streamline their eCTD submission processes.