Automate Across Your
Regulatory Ecosystem

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With deep regulatory functional domain and automation expertise, we built an intelligent automation and orchestration platform to meet the growing demands faced by today’s companies.

Automation
Areas

Most of your writing projects are not “Science” rather well articulated process and template driven activities. Be it a FDA Annual Report or Stability Report or PSUR or CSR and several of them fall into this category. Save time and pain of your team from these.

Automate several RA, safety and clinical related documents and save LOT of your valuable time (from templates, style guides, reviews, project oversight, QC and other mundane activities).
Publishing is Pain and gives no pleasure to anyone.

But somebody needs to take this pain. Leverage REGai to fully automate document level publishing both for WORD and PDF. No other platform in the market does as good as REGai because of its extensive library and intuitive flow.
Most of you have tools already for Submissions especially for eCTD.

But several of other submissions are all done manually currently. Leverage REGai for Submission automation (master to multi-country submissions with 1 click; ROW and other submissions you are building outside your current tools; and more options). REGai comes with strong Template management module to handle different country plans and includes country specific publishing automation. Customize with your process and your standardization.
Important activity but such a drain on Time for all.

Automate Format and Content QC with REGai. Leverage our industry-leading “FIX” functionality to automatically fix issues found in your documents rather than pushing back to authors. Saves time for all.
Digitizing CMC helps immensely in maintenance activities and content generation.

Leverage REGai for CMC digitization (using our NLP engine) and generate content (master to multi-country documents with 1 click; some data driven reports like Stability reports and others). REGai comes with strong Template module to handle different country lists, linking to data (from your DB or LIMS or other excels) and publishing automation. Minimize templates, QC, style guides and other pain areas to save your valuable time. Customize further with your company specific process and other standardization.
Labeling strategy or initial CCDS is “Science” and no automation needed there. But End-to-End management, Label change management (CCDS maintenance, uspi/smpc changes, local label management, QC/Review) and Compliance part can all be linked well to get a proper control of labeling processes in your company. Leverage REGai to manage these processes and induce automation where needed.

Let's separate the signal from the noise

We take a better approach to Regulatory processes and automation. Our platform is designed to provide the adaptability you need to manage everything from simple tasks to complex processes that don’t fit the norm — including those cross Functional/Department as well as IT systems silos and environments. It sounds easy, but we think you’ll find most automation software tools can’t actually do what we do.

Automate & Orchestrate Across Functional / Systems Silos

Get a unified Regulatory automation platform that supports you at every stage of your daily activities. REGai was architected from Day One to overcome Functional & IT silos and to offer the flexibility you need to automate everything from the simplest high-volume tasks to the most complex processes across the entire ecosystem. This enables us to automate things you always wondered “Isn’t there a better way to do this?”, including complex business processes that touch multiple technology tools in your environment, that cross your cloud and on-prem systems.

Keep using current Tools & Systems

Most companies invested lot of time and money already on some of the existing systems. They may be handling some of your business processes well. REGai plugs in across your current Tools / Systems ecosystem, so you have less worries about ripping everything you already invested and replace with REGai. We offer out-of-the-box integrations and pre-built automations that support several business functions.

Our Pre-Built Automations, Process Templates Fuel a Fast Start

Start with REGai in days so you can achieve ROI almost immediately. We don’t think a blank page is the best way to get started when you want to build a new automation, even if you need to customize it for your key processes. And oftentimes, that blank page is the death knell for companies who are trying to onramp automation into their business processes… we don't think getting started with automation has to be that hard. Each of the prebuilt automations can be easily customized with a few clicks to meet your unique needs while getting you up and running in no time.

Whether you are a Cost Center or
Strategic Unit, Automate effectively with Measurable ROI

REGai
Benefits

Access at any time, from anywhere using secure private cloud. REGai can be used as the main system or it can be at the backend (performing functions as batch and complimenting your existing systems).
Whether you're a small-midsized business focusing to become a global company or already have a global presence, we are ready. REGai offers modular approach ensuring you have "fit-for-purpose" platform serving the business processes that matter to you.
REGai offers modular and simple pricing, so there are no surprises. Opt for user license models or Pay-per-Use models depending on your volume and peaks/valleys.
Integrate your existing EDMS or RIM or Quality systems with REGai with pre-built connectors reducing implementation time and costs.

Ready to chat with one of our teams?

The First Step

Let's talk about how DDi can help you