The world's most desirable RIM solution
Regulatory publishing and document management for everyone!
Regulatory Submissions and Registration
e-Regulatory solutions
We are the SE Asian partner for LORENZ, the leading e-regulatory solutions provider to 13 leading government authorities across the world including North America, Europe, and Asia, and the go-to choose for industry when creating and managing product submissions.
Factorytalk offers end-to-end sales, implementation, and support services for LORENZ solutions. Including technical training and on-site consulting. We have completed many implementations in the region, including a full-scale agency project with the Thai FDA, who became the 1st country in ASEAN to implement the eCTD submission format.
We played a crucial supporting role to implement the eCTD infrastructure for the Thai-FDA in 2015 and continuously support the Thai FDA and industries. With years of experience and a deep understanding of regulatory requirements, Factorytalk is well-equipped to help companies navigate the submission process and ensure compliance with Thai FDA regulations. Recently, the Thai-FDA has selected the docuBridge program as their preferred platform for dossier review and approval. Therefore, you can rely on the software and take advantage of its standardized template, efficiency, and quicken the approval process.
Flexible · Efficiency · Fit all work environments!
Why us?
DocuBridge provides companies with a range of this software’s benefits to drive your business with confidence.
Best-In-Class
Trusted by 13 authorities worldwide including the Thai FDA and US FDA.
Cost Saving
Eliminates publishing errors and reduces preparation time
Unlimited publishing
Publishes as many submissions as you’d like with no additional charges
Compliance
Always stay up-to-date with the latest regulatory developments worldwide
Reliability
With a long history of development, customers can count on LORENZ products for stability and ease
Assistance
We provide a well-trained team of technical support (available in English and Thai)
eCTD Options foreveryone.
1 Day Service Station
*Training is available at additional cost
5 or 10 Days Package
docuBridge TWO
FUN FACTS
LORENZ customers
Thousands of companies trust LORENZ for reliable and efficient Regulatory Information management (RIM) solutions.
13
Regulatory Agencies
>1,400
Companies
48
Installed Countries
>1,700
Installations
LORENZ Regulatory Solutions
Regulatory Information Management solutions that fits your regulatory needs.
Compile, publish, import and review submissions such as:
- eCTD
- (V)NeeS
- and other formats for many regions
Submission Management
Manage documents of an application/sequence which requires:
- a lifecycle and versioning
- permission rights
- editing/viewing restrictions
Regulatory Document Management
Validate submissions such as:
- eCTD
- (V)NeeS
- and other formats for many regions
Submission Validation
Automate the standardized processes in your workflow.
Business Automation
Manage changes throughout the entire product life cycle and all product data in a single place:
- Prepare your data for IDMP
- Submit medicinal product data (xEVMPD)
Product Lifecycle Management
Frequently Asked Questions
Find answers to the questions we get asked the most. If you have questions that you can’t find the answer to. Please contact us.
Don’t worry! Our services and program include a comprehensive workshop training course. The half-day session will provide a hands-on experience with the program to ensure your team is all set.
We have a dedicated team of experts who provide technical support and consultancy for any technical problems or program usage questions you may have. Our team is available to assist you throughout the submission process.
docuBridge system comes with a validator tools which will help check if there is any error before it allows you to publish the submission. Also, we are working closely with Thai FDA so we would be among the first to know when the requirements are changing.
Well, nope! 😊 docuBridge is only one of the eCTD submission tools available in the market. As long as the submission tool support Thai eCTD template, there shouldn’t be any problem for you to give it a try. But now since you’re here, why don’t you give us a chance? We are pretty good at what we are doing and you won’t be disappointed!
Want to see
what we can do for you?
Experience Lorenz products for yourself.
