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 choice for industry when creating and managing product submissions.
Factorytalk offer end-to-end sales, implementation, and support services for the LORENZ solutions. Including technical training’s 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 also offer an eCTD submissions service from our Bangkok offices, customers can book to come and create submissions with technical support on-hand.
Flexible · Efficiency · Fit all work environments!
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
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