eCTD Submission System

AKT Health Analytics has partnered with Certara. We are the sole promoters and distributors of Certara's products in India, Bangladesh, Nepal and Sri lanka. We already serve over 100 Pharma companies and CROs with regards to Certaras products.

What is eCTD?

Electronic common technical document (eCTD) submission publishing can be prohibitive and costly with regulatory agencies requiring ever more submission types in electronic formats. Changing regulatory requirements and mandates across markets makes maintaining compliance increasingly difficult. eCTD submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment eCTD managing the entire documentation lifecycle, and meeting your organization’s goals on expediting your release to market.

About GlobalSubmit

GlobalSubmit is a cloud-based eCTD viewer that facilitates an efficient and dynamic regulatory review of your electronic submission process through web-hosted access for all your global activities. Streamline your eCTD review process across your stakeholders with innovative technology.

Certara ensures efficient, timely submissions through our GlobalSubmit eCTD software. GlobalSubmit is a really good platform because it is all integrated, including CROSSCHECK and VALIDATE.

GlobalSubmit CROSSCHECK – Quality control (QC) your hyperlinks and bookmarks 8X faster and 3X more accurate than cumbersome, traditional manual methods.

GlobalSubmit PUBLISH — Publish regulatory compliant PDF submissions for various health authorities

GlobalSubmit VALIDATE — Assess the technical validity of your eCTD submission and eliminate the risk of technical rejection

GlobalSubmit WebReview — Facilitate the timely review of your eCTD submissions across various stakeholders

Benefits of eCTD Software

• Simplify your review process with an anywhere, anytime eCTD viewer.
• Supporting regulatory submissions to major global agencies.
• Meet your organization’s goals on expediting your release to market.
• Confidence and compliance with your eCTD submissions.
• Reduce your QC process of eCTD submissions from hours to minutes.

GlobalSubmit Webreview is a cloud-based eCTD viewer that facilitates an efficient and dynamic regulatory review of your electronic submission process through web-hosted access for all your global activities. Streamline your eCTD review process across your stakeholders with innovative technology that:

• Provides anytime, anywhere browser access with no IT installation required
• Empowers your reviewers through an easy-to-use interface to quickly navigate and search through applications in seconds
• Reduces your risk of costly errors and delays

About AKT Health Analytics

AKT Health is a Healthcare & Life Science Strategy Consulting firm. AKT Health partners with life science companies and health systems to develop a market-leading strategy for long-term top performance, engagement, growth, and sustainability.

Our consultants evaluate data, apply analytical models, study systems, and dissect workflows to unlock opportunities to improve performance through technology enablement and engagement planning. We collaborate with healthcare providers to implement improved processes and create efficiencies that can withstand changes within the industry.

For more information, write to us at info@akthealth.com or Contact us to our Sales Manager – Vijay Anaparthi, Email – vijay@akthealth.com Ph - +917997776410