eCTD Software Reinvented for Today's Regulatory Landscape
Streamline your Regulatory submissions with 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.
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.
KEY FEATURES AND FUNCTIONALITY
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.
SUBMISSIONS TRACKING AND DOCUMENT MANAGEMENT
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.
INSIGHTS & BENEFITS
Revolutionize Your Submissions 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.
Freyr SUBMIT PRO eCTD Subscription Plans
SUBMIT PRO GEO
A starter pack to quickly make your submission.
Per user per year
$3750
SUBMIT PRO LEASE
You can opt for SUBMIT PRO GEO for less than a year.
3 Months
$17506 Months
$2750
SUBMIT PRO ASSIST
An end to end software and publishing services bundle.
Per Year
$24,000
SUBMIT PRO ENTERPRISE
SUBMIT PRO GEO or ASSIST at a scalable level.
Tailor Your Own Plan
Note: All prices mentioned are in USD
