DDi Solution Starters & Use cases
DDi Solution Starters are functional business process solutions that are readily configurable to meet the most demanding enterprise requirements. These are developed using our platforms, that address a common functional or industry use cases.
Unlike conventional packaged solutions, solution starters combine the knowledge and best practices from past implementations with our industry leading workflows to ensure maximum configurability, flexibility, extendibility, and process interoperability. These will help to speed solution time to live, reduce software licensing, implementation, and maintenance costs while reducing risk.
Most of these are backed by our 8-week time to live guarantee. DDi guarantees that the solution framework will be delivered production ready for a fixed services fee within 8 weeks of project sign off.
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Accelerate time-to-live
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Configurable to the more demanding requirements
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Sophisticated & feature rich
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Works seamlessly with other DDi solutions & your systems
- Bio Pharma
- Med Devices
- Consumer Health
- Chemical
Processes covered by DDi’s platforms include:
Regulatory Strategy
Regulatory strategy is often a formal plan that aligns regulatory activities to business strategy, so as to bring a new or modified product to market.
Regulatory Intelligence
Global Regulatory requirements updated frequently, “in-flight” guidance, timely alerts on changes are provided for proactive planning.
Regulatory Project Management
Project management that involves internal / external stake holders while linking all internal documents and ongoing activities is must for any Regulatory team.
Regulatory Information Management
Regulatory Process Management/Automation, Proactive monitoring/alerting of changes, Impact assessment, tracking of products/registrations/changes/project management, Tech documents / dossiers automation improves productivity, reduces compliance cost and saves time for companies.
Regulatory Impact Assesment
Regulatory teams love to quickly and accurately do an impact assessment on Internal changes (product, labeling, commercial) or external changes (regulatory, govt, standards). With disperse data and documents this process is a manual drag in most companies.
Submission Management
Managing constant and timely submissions is of course important. But handling this process easily with proper document traceability and linking Agency communication/emails/responses on queries is a challenge because of disconnected systems.
Publishing Automation
Publishing is Pain. Period. It’s an important step done manually in many companies wasting precious time of Authors and Publishing teams.
Regulatory Document Management
A true regulatory document system will provide a foundation not just for robust document management but future proofing options for documents by giving tools such as embedding data into documents and advanced content management options.
HA Correspondence Centralization
Agency emails in email tools and queries/responses all embedded in email tools. All the knowledge is lost when someone leaves. In addition, someone who want to see previous queries/responses is out of luck.
HA Query/Deficiency Management
Agency queries and especially deficiencies management are important. Simple process that just needs simple solution to keep this efficient with tracking, alerts, content done easily.
Labeling Content Management
Label content is not just documents that need to be managed. Traceability between different countries, reusability, compliance and change management need a different approach.
Labeling E2E Tracking
End-to-End tracking seems easy but what makes it challenging is siloed systems and different business functions involved who may not using same systems. Need a flexible system with workflows and document linkage to make it effective.
CMC Authoring Solutions
CMC authoring is part technical, part science, part process and lot of data. All the authors need is to just have data embedded in documents to make them living documents and reduce manual formatting pain.
Medical Writing Solutions
Medical writing mostly science combined with authors experience. Tools to help automate content generation from tables (or data/tables reused from other documents), auto-formatting and other tools will help streamline writers work.
Structured Content Authoring
Our SCM solution is built upon Component Content Management, and Content Governance that is expandable. The platform is built to offer MS Word-centric reuse and re-purposing of information across document collections. To manage and govern the development, versioning, and release of content components throughout the whole end-to-end regulatory compliance continuum as specified for regulated products and/or services.
Medical Writing Formatting Automation
Medical writers enjoy science, not manual work or formatting. Unfortunately, more than 40% of their time goes into the manual portion.
Medical Writing QC Automation
Verifying documents to reconcile data or reviewing formats is a manual process in most companies.
Clinical Supplies IRT
Handling clinical supply management with different stake holders like sites, depots and clinical teams while maintaining highest level of clinical compliance is key for any clinical study.
Clinical Randomization
Doing Randomization correctly taking few parameters that is dependable is what our randomization solution does.
Processes covered by DDi’s platforms include:
Regulatory Requirements Database
Global Regulatory requirements updated frequently, “in-flight” guidance, timely alerts on changes are provided for proactive planning.
Standards Monitoring
Knowing what standards are changing and what’s in pipeline is important for teams to plan on product or document changes to maintain UpToDate compliance.
Regulatory Impact Assessment
Regulatory teams love to quickly and accurately do the impact assessment on Internal changes (product, labeling, marketing) or external changes (regulatory, govt, standards). With disperse data and documents this is a manual process in most companies.
Regulatory Information Management
Regulatory Process Management/Automation, Proactive monitoring/alerting of changes, Impact assessment, tracking of products/registrations/changes/project management, Tech documents / dossiers automation improves productivity, reduces compliance cost and saves time for companies.
Product/License Tracking
Managing product registrations changes/renewals, agency queries/correspondence and license details to Supply chain and distributors is important.
Affiliate / Distributor Portals
Independent portals that’s a win-win from ease of use and data security perspectives for both manufacturer and 3rd parties / distributors is crucial for business operations.
Regulatory Submission & Publishing
Different countries with diverse application processes and publishing guidelines, a flexible tool to manage various country dossiers is key sot save time and maintain compliance.
Regulatory Document Management
A true regulatory document system will provide a foundation not just for robust document management but future proofing options for documents by giving tools such as embedding data into documents and advanced content management options.
Technical Documents Writing tools
Technical writing whether Risk reports or GSPR or TF or PMS/PSUR or complex reports, tools to help automate content generation from tables (or data/tables reused from other documents), auto-formatting of documents and other aspects will help streamline writers work.
GSPR Automation
Every time technical aspects change, or product names change or description change or standards change or document locations change, you end up changing GSPR manually. See how we automate these steps to make these less manual.
eIFU Portal
eIFU for some companies it’s just compliance and others it’s digitizing labels. Whatever your objective may be, we have several options to fit your needs.
UDI Management
UDI being adapted globally puts a burden on compliance for manufacturers. Internal systems like ERP/PLN not meant for this process, a centralized solution can keep this process compliant within the budget.
Label Content Management
Label content is not just documents that need to be managed. Traceability between different countries, country regulations, eIFU versus Paper, compliance and change management need a different approach.
Label Tracking
End-to-End tracking seems easy but what makes it challenging is siloed systems and different business functions involved who may not using same systems. Need a flexible system with workflows and document linkage to make it effective.
Processes covered by DDi’s platforms include:
Regulatory Requirements Database (Cosmetics, Supplements, Food)
Global Regulatory requirements vary drastically for Consumer health products. We provide frequent updates, “in-flight” guidances, timely alerts on changes to help you plan proactively.
Ingredients Database
Country specific ingredient norms like claims, permissible levels, what’s allowed and not, and labeling requirements are not easy to monitor.
Product/License Tracking
Managing product registrations changes/renewals, agency queries/correspondence and license details to Supply chain and distributors is important.
Submission & Publishing
Different countries with diverse application processes and publishing guidelines, a flexible tool to manage various country dossiers is key sot save time and maintain compliance.
Regulatory Document Management
A true regulatory document system will provide a foundation not just for robust document management but future proofing options for documents by giving tools such as embedding data into documents and advanced content management options.
Label Content Management
Label content is not just documents that need to be managed. Traceability between different countries, reusability, compliance and change management need a different approach.
Label Tracking
End-to-End tracking seems easy but what makes it challenging is siloed systems and different business functions involved who may not using same systems. Need a flexible system with workflows and document linkage to make it effective.
Affiliate / Distributor Portals
Processes covered by DDi’s platforms include:
Product/License Tracking
Managing product registrations changes/renewals, agency queries/correspondence and license details to Supply chain and distributors is important.
Document Portals
Independent portals that’s a win-win from ease of use and data security perspectives for both manufacturer and 3rd parties / distributors is crucial for business operations.
Regulatory Publishing & Submissions
Different countries with diverse application processes and publishing guidelines, a flexible tool to manage various country dossiers is key sot save time and maintain compliance.
Regulatory Document Management
A true regulatory document system will provide a foundation not just for robust document management but future proofing options for documents by giving tools such as embedding data into documents and advanced content management options.
Affiliate / Distributor Portals
Let’s discuss your use cases
Get in touch with us