Freyr Submit Pro

  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 at a 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 SLP, DLP & QC efforts.

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

We cover all major 11 eCTD HA’s (US FDA | EMA | HEALTH CANADA | SWISSMEDIC SFDA | SAHPRA/MCCZA | TGA | EAEU | JFDA | Thai FDA |NMPA |GCC) which makes adhering to Health Authority standards a breeze.

Create compliant document structures with clear and organized layouts to manage documents. Users can expand and collapse the structure to focus on specific sections, and resizing options allow for a customized view, cross-referencing capabilities.

Decrease publishing efforts by 57% through automation of manual tasks, leading to a substantial reduction in error rates.
Make Your Regulatory Submissions Seamless


Efficiently Create, Validate, and Manage eCTD Submissions

Efficiently Create, Validate, and Manage eCTD Submissions

Automatically check submission compliance with our 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 submissions, cutting down on manual input and repetitive tasks.

With SUBMIT PRO, Regulatory professionals can quickly navigate and utilize region-specific eCTD templates to make different types of submissions like 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 submission lifecycles across all major regions with an in-built viewer, ensuring transparency and understanding.

Optimize document and submission-level tasks using RPA & ML modules helping in reduced manual interventions and enhanced accuracy.


Precision at Its Core: Configure Once, Reap Benefits Always

Ensure your 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 submissions with unique identifiers. Our system retains all metadata, ensuring the relevance and integrity of hyperlinks and references for each new submission.

Experience seamless document migration from any platform to Freyr SUBMIT PRO. Our robust import utility simplifies the transition of previous submissions into our system, enhancing lifecycle management and overcoming traditional submission challenges.
Precision at its core. Configure once, reap benefits always.


Revolutionize Your Submissions with Efficiency

Revolutionize the way you submit with efficiency

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

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

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


Freyr SUBMIT PRO eCTD Subscription Plans


    A starter pack to quickly make your submission.

    Per user per year   

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

    3 Months   

    6 Months   

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    An end to end software and publishing services bundle.

    Per Year   

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

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