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Freyr SUBMIT PRO - eCTD Submission Software
Freyr SUBMIT PRO is an advanced electronic Common Technical Document (eCTD) submission software, designed to streamline the regulatory submission processes across the pharmaceutical and life sciences industries. The platform integrates multiple functionalities such as an intelligent validator tool, which ensures precise compliance with eCTD standards, and an automated publishing workflow that reduces the manual workload. It is compatible with leading electronic Document Management Systems (eDMS) and supports seamless data migration and document reuse, ensuring both efficiency and accuracy. Freyr SUBMIT PRO is compliant with 21 CFR Part 11 regulations, offering a touchless submission process and a user-centric interface. Its subscription plans are flexible, offering features suitable for varying needs, from starter packs to enterprise-level services, making it a comprehensive solution for companies aiming to simplify and enhance their regulatory compliance efforts.
Best eCTD Submission Software Reinvented for Today's Regulatory Landscape
Streamline your Regulatory submissions with Freyr SUBMIT PRO by accessing Simple processes, Measurable outcomes, Automated workflows, Robust compliance, and Tech-Driven innovations into one platform. Accessible whenever you need, wherever you are.
Facing Regulatory Submission Delays?
Accelerate your reviews with our inbuilt eCTD validator by identifying up to 800 errors, one time.
Juggling Between Multiple Platforms?
Integrate your existing software with Freyr SUBMIT PRO and consolidate your Regulatory submissions toolkit under one roof.
Losing Time on Tedious Tasks?
Embrace automation for tasks like bookmarking, hyperlinking, and managing PDFs and save up to 25% time on QC efforts.
Tired of Intensive Training Sessions?
No need for hours of training or complex manuals. Dive right in with our user-friendly interface eCTD software and start working.
Navigating the Maze of Regulatory Compliance?
We cover all major 13 HA’s (US FDA | EMA | HEALTH CANADA | SWISSMEDIC SFDA | SAHPRA/MCCZA | TGA | EAEU | JFDA | Thai FDA | ASEAN|NPRA |NMPA |GCC) which makes adhering to Health Authority standards a breeze.
Struggling with eCTD Structures?
Create compliant document structures with a clear and organized layouts to manage Regulatory documents. Users can expand and collapse the structure to focus on specific sections, and resizing options allow for a customized view cross-referencing capabilities and resizing options enabling customization.
Worried About Manual Mistakes?
Reduce Regulatory publishing efforts by 57% by automating hands-on tasks and watch those error rates drop significantly.
Efficiently Create, Validate, and Manage eCTD Submissions
Intelligent Validator Tool
Be it FDA Submission or any other, Freyr SUBMIT PRO automatically check submission compliance with its in-built validator, minimizing errors and ensuring adherence to guidelines.
Integrated with Leading eDMS Platforms
Seamless synchronization with top electronic Document Management Systems guarantees a smooth workflow transition.
Touchless Submission Process
Leverage module cloning and an inbuilt PDF manager to streamline Regulatory submissions, cutting down on manual input and repetitive tasks.
User-Centric Design
With Freyr SUBMIT PRO, Regulatory professionals can quickly navigate and utilize region-specific eCTD templates to make different types of submissions like IND, NDA, BLA etc. (for more details check Freyr SUBMIT PRO) ensuring an efficient eCTD submission process. The intuitive interface reduces the learning curv
Comprehensive eCTD Viewer
Review eCTD submissions lifecycles across all major regions with an in-built viewer, ensuring transparency and understanding.
Automated eCTD Publishing Workflow
Utilize RPA & NLP modules to optimize document and submission-level tasks, reducing manual interventions and enhancing accuracy.