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pharmaREADY® eCTD
Providing electronic Common Technical Document support for the publishing of Regulatory Submissions to comply with Regulatory Health Authority requirements
What is an electronic Common Technical Document (eCTD) and how can it benefit your submissions?
The US Food and Drug Administration (FDA) defines the eCTD as ‘the standard format for submitting applications, amendments, supplements, and reports to the FDAs Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).’ By leveraging eCTD, you’re not just meeting FDA expectations—you’re enhancing your workflow, accelerating time to approval, and building trust with regulatory authorities. It’s a smarter way to navigate the regulatory landscape and bring your innovations to life.
Our pharmaREADY® eCTD module enables first-time-right submissions that comply with Regulatory Health Authority (HA) requirements. We pride ourselves on being eCTD-ready for all agencies so that your organization can both create and manage global and compliant submissions. To date we have managed 250,000+ submissions.
pharmaREADY® eCTD supports submissions to:
- US FDA
- EMA
- Health Canada
- Swiss Medic
- SAHPRA
- TGA
- Thai FDA
- Jordan FDA
- GCC
- EAEU
- China
- WHO
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eCTD Submissions
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NeES Submissions
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Paper Submissions
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Regulatory Professionals
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Years of Average Experience
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Customers
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Technologies
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Health Authorities
We offer comprehensive Submission Management and Publishing Services that cover the whole Product Life Cycle, including Initial submissions (IND), New Drug Application (NDA) and post-approval fillings. Our experienced team of 250+ Regulatory experts use pharmaREADY® eCTD to support organizations in the execution of End-to-End submission and publishing activities. Our services include:
- Document authoring and compilation
- Submission and Publishing
- Submission Archival
- HA Correspondence archiving and tracking
Wherever possible, we have implemented automation principles that were created as part of continuous improvement into practice. Regulatory experts with practical experience supporting large, mid-sized, and small business clients, as well as client feedback, helped us to improve the submission publishing and compilation process, which helps to shorten the time it takes to produce the eCTD package and thus the time it takes for approval.
- Submission Build Automation
- Automated file naming for all the modules
- Fit and Finish – Document, Report Level Publishing
At Navitas Life Sciences we adopt a multi-tenant model to provide services to our clients. This model is fully validated, ready for use, cost-effective, and requires less than a week to implement. It is also worth noting that we assure fully secure data for each client. You can access the system to track and view dynamic reports, as well as manage queries and resolutions until the submission is dispatched to the Health Authority and archival.
The eCTD module provides:
- A submission roadmap
- A platform for structured creation
- Document assembly: including a drag and drop feature for ease
- The ability to clone and reuse existing submissions using comprehensive templates. All module templates are compliant with the latest ICH and regional specifications.
- A complete workflow for all stakeholders with work-in-progress status and final preview
- Internal review
- Automated file naming for all modules based on ICH and regional file naming guidelines
- Sequential and parallel approval cycles
- Compilation
- Comprehensive validation engine
- Publishing
Available as an independent product, or as part of an integrated package with our other modules, pharmaREADY® eCTD is available for
Pharmaceuticals
Biologics and Biosimilars
Medical Devices
Generic Drugs
Animal Health
Can your Regulatory Technology drive accelerated compliance and deliver
First-Time-Right Submissions?
For a LIVE DEMO or to learn more about pharmaREADY® eCTD
