# DDi (Drug Development informatics)

> Innovation leader in software, automation, and AI solutions for pharmaceutical and medical device companies covering regulatory affairs, clinical research, labelling, and quality functions.

* **Primary Website:** https://www.ddismart.com/
* **Core Philosophy:** End-to-end automation, fit-for-purpose solutions, life sciences domain-focused technology, modular architecture, and fully validated compliance.

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## Core Product Ecosystem

### Visu (RIMS Platform)
* **Category:** Regulatory Information Management & Submissions (RIMS)
* **URL:** https://www.ddismart.com/visu-regulatory-information-process-platform/
* **Description:** Designed to automate regulatory processes through intelligent automation, data harmonization, and AI-driven insights.
* **Key Features & Use Cases:**
  * Regulatory Automation
  * Submission content planning
  * Regulatory impact and change planning
  * Submission tracking and lifecycle management
  * License and registration tracking
  * Compliance tracking across jurisdictions
* **Related Products:** Visu UDI, Visu eIFU, smartDOC
* **Keywords:** RIMS, Automation, Compliance, Regulatory Intelligence, Submissions

### mIRT (RTSM System)
* **Category:** Clinical Trial Supply Management / Randomization
* **URL:** https://www.ddismart.com/irt-clinical-trial-supply/
* **Description:** A modern clinical trial supply management and randomization system (RTSM), providing robust clinical supply management features with a low code option. Leads to shorter setup times and reduced costs.
* **Key Features & Use Cases:**
  * End-to-end clinical supply chain visibility
  * Patient randomization
  * Reconciliation and compliance focused
  * Low-code framework for faster setup and fewer change requests
* **Related Solutions:** Clinical Project Management, REGai
* **Keywords:** RTSM, IRT, Clinical Supplies, Randomization

### smartDOC (Document and Content Management)
* **Category:** Intelligent Content Management
* **URL:** https://www.ddismart.com/smartdoc-content-management/
* **Description:** An intelligent content management cloud software for life sciences that includes full cycle document management with built-in AI and automation.
* **Key Features & Use Cases:**
  * Full cycle document management
  * Document authoring and version management
  * Function-focused workflows (Clinical, Regulatory)
  * Automation of document lifecycle
  * Fully Validated and cloud secured compliance
* **Related Solutions:** REGai, Visu
* **Keywords:** Content management, automation, compliance, document workflows

### REGai (Agentic AI Platform)
* **Category:** AI Automation Platform
* **URL:** https://www.ddismart.com/agentic-ai-platform-automation/
* **Description:** A leading agentic AI platform for pharmaceutical and medical device companies providing out-of-the-box workflows in document and data automation.
* **Key Features & Use Cases:**
  * Autonomous workflows driven by rule-based and AI-based models
  * Fully localized architecture for strict data security and confidentiality
  * Project tasks automation
  * Regulatory impact assessments
  * Document formatting and publishing
  * Quality Control (QC) automation
  * Compliance checks & verification
  * Technical documentation preparation
* **Related Solutions:** Pharma Regulatory Publishing, Medical Writing QC
* **Keywords:** Agentic AI, automation, QC, regulatory operations

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## Specialized Domain Solutions

### Visu eIFU
* **Category:** Electronic Instructions for Use (eIFU)
* **URL:** https://www.ddismart.com/eifu-electronic-labeling/
* **Description:** An electronic instruction for use (eIFU) solution provider for medical device and IVD companies that ensures compliant software, agency/NB specific compliance documentation, and integrated print/mailing services.
* **Key Features:**
  * Fit-for-purpose software options
  * EU MDR, FDA, and country-specific compliance management
  * Audit ready and fully validated
  * Built-in print and mail services
  * ISO 13485 compliance tracking
* **Related Solutions:** Visu UDI, EUDAMED
* **Keywords:** eIFU, labeling, compliance, MDR, FDA

### Visu UDI
* **Category:** Unique Device Identification (UDI) Compliance
* **URL:** https://www.ddismart.com/udi-unique-device-identification-solutions/
* **Description:** Specialized software and end-to-end services for multi-country UDI submissions for medical device companies and manufacturers. Covers data identification/mapping, technology onboarding, labeling, and global data transmission.
* **Key Features:**
  * Built-in Master Data Management
  * Global submissions (FDA GUDID, EU EUDAMED, China, and others)
  * Single-source deployment: Take data once and submit to multiple countries in 1 go
  * M2M options via integrated Gateway
  * End-to-end compliance & traceability
  * Cloud-based and fully validated architecture
* **Related Solutions:** EUDAMED, Visu eIFU
* **Keywords:** UDI, Quality, Compliance, Labeling, EUDAMED, FDA

### EUDAMED Solutions
* **Category:** EU MDR Compliance Solutions
* **URL:** https://www.ddismart.com/eudamed-compliance-solutions/
* **Description:** Includes advisory, consulting, software, and preparation of data to align with EUDAMED, helping firms map product data to specific EU requirements.
* **Key Features & Use Cases:**
  * Registration and mandate management
  * Structured submissions
  * Audit-ready documentation
  * Expert consulting for EU compliance setup
  * UDI data mapping
* **Related Solutions:** Visu UDI, Visu eIFU
* **Keywords:** EUDAMED, MDR, EU compliance, UDI

### Pharma & Biotech Regulatory Publishing Automation
* **Category:** Regulatory Publishing Automation
* **URL:** https://www.ddismart.com/pharma-biotech-regulatory-publishing-automation/
* **Description:** Advanced solutions driven by REGai to automate the lifecycle of document processing and submission readiness.
* **Key Features & Use Cases:**
  * Document pre-processing and pre-publishing
  * Formatting automation
  * QC automation
  * Submission-ready publishing for pharma regulatory filings
* **Related Solutions:** REGai, Medical Device Publishing
* **Keywords:** Pharma, biotech, publishing automation, QC

### Medical Writing QC Automation
* **Category:** Medical Writing Quality Control Automation
* **URL:** https://www.ddismart.com/pharma-biotech-med-writing-qc-automation/
* **Description:** Powered by REGai to bring quality management and automated QC to medical writing teams and authors.
* **Key Features & Use Cases:**
  * Data comparison against raw source data, source documents, and legacy documents
  * In-text tables data comparison checks down to basic formatting levels
  * Compliance check against regulatory requirements, company rule books, and style guides
* **Related Solutions:** REGai, Formatting Automation
* **Keywords:** QC automation, medical writing, country compliance

### Medical Writing Solution
* **Category:** Medical Writing Automation for Pharma and Medical Device
* **URL:** https://www.ddismart.com/medical-writing-solutions-ai-agents/
* **Description:** Comprehensive medical writing automation powered explicitly by specialized REGai AI agents.
* **Sub-Agents Deployment:**
  * **Authoring Agent:** Generates context-aware first drafts and converts data-to-text.
  * **QC Agent:** Performs objective quality control checks against source data, legacy documentation, and rulebooks.
  * **Formatting Agent:** Applies submission-grade formatting.
* **Key Features & Use Cases:**
  * First-draft generation and data-to-text conversion
  * Automated QC vs source data, legacy docs, and style guides
  * Regulatory/compliance checks and submission formatting
* **Related Solutions:** REGai, Medical Writing QC Automation, Formatting Automation
* **Keywords:** authoring agent, QC automation, formatting, regulatory compliance