AI Agents for Regulatory Strategy for BioPhama & Devices

Strategy, Intel & Impact AI Agents

Ready to Go !

Too much Data. Too little Direction.

Regulatory, Clinical and Project teams operate in data abundant and sometimes chaotic environments. Several data sources, Agency alerts, internal excels, & 3rd party subscriptions. Multiple stakeholders need different levels, varied contexts and formats. By the time your existing systems or teams gather updated info, build some data or reports or analysis, it’s late. So, the problem isn’t access to data. The problem is Absorption. Faster and contextual access is key.

Regulatory Insights Agent

Stay ahead of ever-changing regulations without the manual grind. This AI agent scans new guidelines, regulations and distills them into clear, relevant requirements and insights for your teams aligned by country and product areas.

Regulatory Impact Agent

External changes and internal changes happen every day. Doing impact on each of these to ensure products stay compliant and don’t lose value is an important step, yet heavily manual. Impact Agent takes these changes and analyses to determine impact area by function, product, or process. Combining with other agents, this can save hours and help you act with confidence.

Regulatory Strategy

Regulatory teams aren’t lacking data, they’re missing clarity. This agent provides Strategy options: using automation to surface what’s working, why it’s working, and how to prove it. It pools siloed data, reviews your historical plans (if exist) and deliver management-ready narratives.

Change Planning & Actions

Action items based on regulatory changes impacting a process or a product involve several manual steps and time consuming. Leverage our agent that can create steps and actions based on the assessments and available data. It can connect to our project tools or can create actions and activities in any of your current tools.

How our Agents Help Your Strategy Teams

DDi empowers Strategy teams to automate routine tasks, manual activities and processes – freeing them to focus on stake holder engagement and project delivery on-time/on-budget.

+70%

More Insights vs Manual

4x

Faster Response Times

50%

Cost Reduction

Illustrative Workflow Templates

Deploy your Platform AI Agents in 4 Easy Steps

Agent Discovery

Conduct workshop(s) with relevant stakeholders to identify and prioritize use cases and map the requirements.

Agent Setup

Develop and launch your first agent with basic logic and integration (process scoping and recording, test dataset with few examples, baseline agent running and testing with target output mapping).

Agent Training

Test performance and gather feedback from process users (agent optimization up to 80% against expected output, variable-level accuracy measurement and optimization, integrations setup, and feedback).

Agent Live

Extend to more workflows and other teams (live and continuous monitoring, human-in-the loop interfacing, automated prompt enhancements, >90% accuracy improvement, constant business logic improvements).

Want AI to optimize your regulatory strategy and Assessments?

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