This is our client feedback which says our product is a leading eCTD tool and is much more better than many of our competitors like Cunesoft, Extedo, Master Control, Veeva Systems or any other eCTD tool

  We are using Freyr SUBMIT PRO since 2016. It is very user-friendly and time to time updating as per Regulatory requirements and for software improvisation. The customer support from Freyr Digital is very satisfactory.

- Leading Indian Pharma Company

accelerate and streamline

Make Your Regulatory Submissions Seamless

Accelerate your reviews with our inbuilt eCTD validator by identifying up to 800 errors, one time.

Integrate your existing software with Freyr SUBMIT PRO and consolidate your Regulatory submissions toolkit under one roof.

Embrace automation for tasks like bookmarking, hyperlinking, and managing PDFs and save up to 25% time on QC efforts.

No need for hours of training or complex manuals. Dive right in with our user-friendly interface eCTD software and start working.

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.

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.

Reduce Regulatory publishing efforts by 57% by automating hands-on tasks and watch those error rates drop significantly.
By adhering to ISO 27001 standards, companies can safeguard confidential Regulatory submissions, maintain data integrity, and reduce the risk of breaches, be it for FDA format (eCTD FDA), ind submission or any other eCTD submissions

KEY FEATURES AND FUNCTIONALITY

Efficiently Create, Validate, and Manage eCTD Submissions

Regulatory Submissions or the eCTD submissions follow a proper eCTD structure to which the features of our eCTD software are aligned with and hence it helps with seamless Regulatory submissions

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.

Seamless synchronization with top electronic Document Management Systems guarantees a smooth workflow transition.

Leverage module cloning and an inbuilt PDF manager to streamline Regulatory submissions, cutting down on manual input and repetitive tasks.

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 curve.

Review eCTD submissions lifecycles across all major regions with an in-built viewer, ensuring transparency and understanding.

Utilize RPA & NLP modules to optimize document and submission-level tasks, reducing manual interventions and enhancing accuracy.

COMPLIANCE AND DOCUMENT MANAGEMENT

Precision at its core. Configure once, reap benefits always.

Ensure your Regulatory submissions always align with current regulations. With inbuilt eCTD validation tools, ensure adherence to the Code of Federal Regulations (CFR) 21 part 11 of the FDA and the European Union Good Manufacturing Practice (EU GMP) Annex 11.

Effortlessly reference and reuse documents across multiple eCTD submissions with unique identifiers. Our system retains all metadata, ensuring the relevance and integrity of hyperlinks and references for each new Regulatory submission.

Experience seamless document migration from any platform to Freyr SUBMIT PRO. Our robust import utility simplifies the transition of previous eCTD submissions into our system, enhancing lifecycle management and overcoming traditional Regulatory submissions challenges.
Submission Management being the top objective of this eCTD software it looks after filing FDA, looking for different types of FDA submissions and eCTD publishing

INSIGHTS & BENEFITS

Revolutionize the way you submit with efficiency.

Freyr SUBMIT PRO is the top eCTD tool that helps you with Regulatory submissions and hence act as a best Regulatory Information Management System

With our decade+ history of 100,000+ Regulatory submissions across all major Health Authorities and a growing community of over 3,350 users, we've developed a groundbreaking automation toolkit, integrating RPA & NLP technologies for unparalleled efficiency.

Our automation capabilities span from managing PDF properties to assigning eCTD documents, thoroughly streamlining the Regulatory submission process and achieving an impressive 99.8% increase in document quality.

Transform a 90-day NDA Regulatory submission process into a swift 30-day task. Experience peak efficiency.

 

Freyr SUBMIT PRO eCTD Subscription Plans

  • Freyr SUBMIT PRO

    SUBMIT PRO GEO

    A starter pack to quickly make your submission.

    Per user per year   
    $4125

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  • Freyr SUBMIT PRO

    SUBMIT PRO LEASE

    You can opt for SUBMIT PRO GEO for less than a year.

    3 Months   
    $1925

    6 Months   
    $3025

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  • Freyr SUBMIT PRO

    SUBMIT PRO ASSIST

    An end to end software and publishing services bundle.

    Per Year   
    $26400

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  • Freyr SUBMIT PRO

    SUBMIT PRO ENTERPRISE

    SUBMIT PRO GEO or ASSIST at a scalable level.

    Tailor Your Own Plan   
     

    Contact Us

Note: All prices mentioned are in USD

Because Regulatory submissions require seamless teamwork.

Elevate the way your Regulatory team works. With collaborative Regulatory submission preparation and review functionalities, ensure that your team is always on the same page. Experience Freyr SUBMIT PRO and discover how Freyr can transform your Regulatory submission processes.

Let's Talk  www.ectdtool.com