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RWS | Tridion One
RWS is a trusted partner to 9 of the top 10 leading pharmaceutical organizations, delivering an end-to-end solution that includes the generation and translation of accurate and compliant documentation.
From discovery to post-approval commitments, our world class technology integrates structured content with AI-readiness to empower pharma content across use cases in:
- CMC
- Labelling
- Clinical
- Regulatory
Tridion One, formerly Fonto One, is the only solution specifically designed to eliminate legacy documentation risk and future-proof regulatory content with AI-ready approaches to authoring and content management. Built in partnership between RWS content experts and pharmaceutical companies’ regulatory documentation specialists.
Structured content authoring (SCA) and structured content management (SCM) are key elements in managing documentation at a granular, data level. By breaking documents into FAIR, metadata-rich components, Tridion One:
- Establishes a single source of truth: eliminates version creep and ensures all authors work from the same validated content base. Tridion One Templates support content reuse across various regulatory documents and automate content updates using data-driven features like Smart Placeholders and Smart Tables.
- Enables secure, value-driven AI: transforms unstructured documents into verified, AI-ready data streams.
- Secures compliance: enforces regulatory structure and audit trails by design. Conditional content within templates automatically includes or excludes sections based on the specific data requirements of the final document, driving core automation.
Trados, Language Weaver, and expert life sciences services streamline global regulatory content. Blending AI-enabled technology with human expertise, we help teams accelerate submissions, improve quality, and scale sustainably while collaborating more effectively across markets to support innovation and better patient outcomes.
Benefit area | Description |
| Generate first drafts faster with AI | Slash authoring, review, and approval times by combining pre-approved content reuse with AI-generated first drafts from your LLM. |
| Collaborate more easily | Enable real-time, multi-user collaboration in an intuitive, familiar editor to efficiently manage even the most complex documents and streamline the entire review cycle. |
| Improve content consistency and variation control | Maximize efficiency by reusing pre-approved content. Give editors the control to instantly view and selectively propagate content or data changes across applicable templates and documents. |
| Save time and effort with automated output | Publish effortlessly by generating multiple outputs (Word, PDF, XML, JSON, FHIR) and integrating with connected systems to fuel RIM and AI applications from your single working document. |
| Meet translation and localization requirements faster and cheaper | Achieve efficient, compliant translation by integrating Tridion One with RWS Trados Enterprise to track content component relationships and automate the push-pull of reviewed content. |
| Streamline dossier submission | Modularizing the dossier structure allows teams to rapidly create and assemble submissions using reusable, pre-defined templates tailored for specific therapeutic and entity types. |
| Optimize compliance | Simplify compliance and reduce risk through robust content. |
| 1. Data generation | 2. Data preparation | 3. TLF¹ generation |
|---|---|---|
| Real-time regulatory intelligence hub knowledge base capability, with latest global and regional health authority requirements; end-to-end digital data flow, from protocol to submission. | Gen AI-assisted clinical data cleaning, review, query generation, and reconciliation; automated data transformation (e.g. study data tabulation model, analysis data model). | Predefined, set number and type of TLFs in workflows; Gen AI-assisted TLF programming, generation, formatting, and audit trails. |
| 4. Drafting and labeling | 5. Review | 6. Quality control |
| Gen AI-assisted drafting, automated formatting, and style guide checking; structured content management; digitized label platform, including automated propagation of changes from company core data sheet to local template. | Auto-suggestions for initial drafts and auto-consolidation of comments. | Automated quality control and source data validation of in-text TLFs; automated validation of compliance with controlled terminologies, abbreviations, and CDISC² standards. |
| 7. Publication | 8. Local translation | 9. HAQ³ management |
| Enhanced, continuous publication, leveraging regulatory intelligence hub and automated publishing tools. | Real-time population of local templates; automated translation for ‘rest of the world’ filings from electronic common technical document. | Real-time population of HAQ repository; integrated HAQ workflow, with AI-assisted response drafting based on HAQ repository. |
¹Tables, listings and filings.
²Clinical data interchange standards consortium.
³Health authority query.
Source: Faster regulatory submissions for pharma | McKinsey & Company
RWS is a trusted partner to 9 of the top 10 leading pharmaceutical organizations, delivering an end-to-end solution that includes the generation and translation of accurate and compliant documentation.
From discovery to post-approval commitments, our world class technology integrates structured content with AI-readiness to empower pharma content across use cases in:
- CMC
- Labelling
- Clinical
- Regulatory
Tridion One, formerly Fonto One, is the only solution specifically designed to eliminate legacy documentation risk and future-proof regulatory content with AI-ready approaches to authoring and content management. Built in partnership between RWS content experts and pharmaceutical companies’ regulatory documentation specialists.
Structured content authoring (SCA) and structured content management (SCM) are key elements in managing documentation at a granular, data level. By breaking documents into FAIR, metadata-rich components, Tridion One:
- Establishes a single source of truth: eliminates version creep and ensures all authors work from the same validated content base. Tridion One Templates support content reuse across various regulatory documents and automate content updates using data-driven features like Smart Placeholders and Smart Tables.
- Enables secure, value-driven AI: transforms unstructured documents into verified, AI-ready data streams.
- Secures compliance: enforces regulatory structure and audit trails by design. Conditional content within templates automatically includes or excludes sections based on the specific data requirements of the final document, driving core automation.
Trados, Language Weaver, and expert life sciences services streamline global regulatory content. Blending AI-enabled technology with human expertise, we help teams accelerate submissions, improve quality, and scale sustainably while collaborating more effectively across markets to support innovation and better patient outcomes.
Benefit area | Description |
| Generate first drafts faster with AI | Slash authoring, review, and approval times by combining pre-approved content reuse with AI-generated first drafts from your LLM. |
| Collaborate more easily | Enable real-time, multi-user collaboration in an intuitive, familiar editor to efficiently manage even the most complex documents and streamline the entire review cycle. |
| Improve content consistency and variation control | Maximize efficiency by reusing pre-approved content. Give editors the control to instantly view and selectively propagate content or data changes across applicable templates and documents. |
| Save time and effort with automated output | Publish effortlessly by generating multiple outputs (Word, PDF, XML, JSON, FHIR) and integrating with connected systems to fuel RIM and AI applications from your single working document. |
| Meet translation and localization requirements faster and cheaper | Achieve efficient, compliant translation by integrating Tridion One with RWS Trados Enterprise to track content component relationships and automate the push-pull of reviewed content. |
| Streamline dossier submission | Modularizing the dossier structure allows teams to rapidly create and assemble submissions using reusable, pre-defined templates tailored for specific therapeutic and entity types. |
| Optimize compliance | Simplify compliance and reduce risk through robust content. |
| 1. Data generation | 2. Data preparation | 3. TLF¹ generation |
|---|---|---|
| Real-time regulatory intelligence hub knowledge base capability, with latest global and regional health authority requirements; end-to-end digital data flow, from protocol to submission. | Gen AI-assisted clinical data cleaning, review, query generation, and reconciliation; automated data transformation (e.g. study data tabulation model, analysis data model). | Predefined, set number and type of TLFs in workflows; Gen AI-assisted TLF programming, generation, formatting, and audit trails. |
| 4. Drafting and labeling | 5. Review | 6. Quality control |
| Gen AI-assisted drafting, automated formatting, and style guide checking; structured content management; digitized label platform, including automated propagation of changes from company core data sheet to local template. | Auto-suggestions for initial drafts and auto-consolidation of comments. | Automated quality control and source data validation of in-text TLFs; automated validation of compliance with controlled terminologies, abbreviations, and CDISC² standards. |
| 7. Publication | 8. Local translation | 9. HAQ³ management |
| Enhanced, continuous publication, leveraging regulatory intelligence hub and automated publishing tools. | Real-time population of local templates; automated translation for ‘rest of the world’ filings from electronic common technical document. | Real-time population of HAQ repository; integrated HAQ workflow, with AI-assisted response drafting based on HAQ repository. |
¹Tables, listings and filings.
²Clinical data interchange standards consortium.
³Health authority query.
Source: Faster regulatory submissions for pharma | McKinsey & Company
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