BioPharma – Business & Functional Solutions
Maintaining compliance and regulation standards, in addition to the constant initiative to reduce operation costs as well as productivity improvements, makes Digitization, BPM, and Automation vital solutions for Pharma and Biotech companies. DDi platforms provide value-added benefits over other existing enterprise applications such as ERP, EDMS, delivering a process improvement, analytics and optimization solutions that connects people and systems across your organization.
DDi ensures that our BioPharma customers realize the enormous benefits of digital business processes: security, compliance, accountability, process visibility, responsiveness, mobility, and cost efficiency. And our proven, industry-leading, enterprise level digital technologies achieve these benefits with higher speed of delivery, performance, flexibility, and cost effectiveness.
The challenges facing BioPharma departments demand process modernization. Remote work; expectations of digitally savvy customers; competition from new, often digital entrants; risk-prone manual processes; and siloed automation efforts all threaten firms that do not plan properly or move aggressively.
Improved Agility with Adaptive Discovery
With hundreds of adaptive features built into our platforms, process adaptation and improvement to meet constantly changing business needs is considerably faster than with applications that require customization or programming.
Leveraging Existing IT Systems
DDi extends the value of existing IT systems by automating cross-enterprise processes and passing information in and out of existing systems such as ERP, Financial, and Document Management systems and databases.
Real Time Visibility and Control of Metrics
DDi reporting and business function activity monitoring provides the transparency that managers demand to best understand how their core processes are performing and keep them proactive.
Tighter Compliance
Not only are processes automated in order to provide faster response and lower operating costs, but all processes align with country specific regulations with Reg Intel built-in.
Each of the DDi’s four key platforms excels in its category and, together, add up to enterprise-level digital transformation
ViSU (Regulatory Information & Process Management) platform with pre-built modules that translates business-level requirements into unified families of production-ready and seamless software applications
REGai (Regulatory Automation) platform that includes AI, NLP and Business rule driven automation foundation with several solutions that are readily configurable to meet most of the Regulatory function requirements
Vistaar (Regulatory Intelligence) platform that blends Technology and regulatory experts to drive monitoring and mitigate compliance risks
smartDOC (Content Management) platform that flexes from a basic document management needs to advanced component structure that empowers users while making documents “future proof”
Processes covered by DDi’s platforms include:
-
Regulatory Strategy
-
Regulatory Intelligence
-
Regulatory Project Management
-
Regulatory Information Management (RIM)
-
Regulatory Impact Assesment (RIA)
-
Submission Management
-
Publishing Automation
-
Regulatory Document Management
-
Structured Content Management (SCM)
-
HA Correspondence Centralization
-
HA Query/Deficiency Management
-
Labeling Content Management
-
Labeling E2E Tracking
Let’s discuss your use cases
Get in touch with us