Pharmaceutical corporations face challenges distinctly unique in formula-based manufacturing. They face continually changing healthcare legislations, disparate R&D facilities, complex drug portfolios, and increasing competition in nearly every market.
DevEXRx equips pharmaceutical companies to collaborate more effectively, ensure traceability, ensure compliance, generate documentation, and expedite products to market.
Key Features and Benefits
Structured Drug/Product Development Record (ePDR)
- Integrated New Product Development based on Quality by Design (QbD) principles
- Experiment/Trial Hierarchy
- Configurable formula views with ability to compare and contrast multiple formulas
- Optimize formulas to meet target objective and defined constraints (costs, alternate ingredients, etc.)
- View vendor specifications throughout development
- Global Product Registration of E Common Technical Documents (eCTD)
- Raw Material Management
- Leverage knowledge base
- Integrated regulatory compliance analysis and views
Regulatory Compliance
- ICH Q8-Q10 applicable over entire product lifecycle
- Creation of eCTD for filing
- View hierarchy of a molecule and all materials used in a molecule
Technology Transfer and Collaboration
- Innovation Process Management
- Knowledge Management
- Phase Gate for task assessment and approval
- Portfolio & Project Management
- Task list upon login
- Supervisor Views
- Templates for faster development
- Roles and responsibilities defined for Qbd-based PDR
- Change/Version Control to track molecule history and changes
Integrated Quality & Risk Management
- Clinical Trial Management
- Leverage Common Technical Documents (CTD)
Packaging And Label Management
- Integrated with product development database for greater accuracy:
- Content Claims
- Allergens
- Safety Statements
- Configurable templates
- Near-camera ready artwork
- Multiple language support for translations
- Secured Supplier Site for uploads of artwork, specifications, delivery, etc.