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Regulatory Automation – Improve Productivity, Save Costs

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.



Most of your writing projects are not “Science” rather well articulated process and template driven activities. Let the document be a CSR, PSUR, some of CMC documents, Annual Reports and several others fall into this category. Lot of these documents need data to be converted to tables. Save time and costs and improve efficiency.

Automate several RA, Clinical and safety and clinical related documents and save LOT of your valuable time (from templates, data tables, formatting, reviews, project oversight, QC and other manual activities).


Publishing is Pain and several steps are heavily manual

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, integration to EDMS systems (to automate document processing) and underlying robust platform


Most of you have tools already for Submissions especially for eCTD

But several of other submissions are all done manually currently. Leverage our solution 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 submission 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 document owners. Automate post-publishing activities like Dossier validation (and fixing file or Leaf names automatically). Saves time for all

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.

Building Blocks

Runtime Automation

Forget about manually logging into different systems or building and maintaining custom interfaces. You only need to focus on what you want to achieve. Simply create or import your workflows/rules and start building and deploying automated jobs. You can use parameterization, templates, conditionals and functions to deal with any of your daily jobs. Then save & share them with others and schedule jobs of all your process configs to keep control of what changes in production. This powerful engine alone will solve most of your daily automation needs. It serves as the foundation for other solutions provided in the platform.

Cross-Application Workflows

Cross-application workflow is the core component of REGai automation and provides the foundation for the rest of the building blocks. This allows REGai to move, add, change, and delete for multiple applications in one go – removing the need to re-enter the same information several times to provide phone numbers, voicemail, meeting applications, etc. Cross-application workflow can dramatically reduce the time it takes your teams to carry out mundane tasks from minutes to seconds.

Data-driven Automation

Now let’s go one step further and truly boost your automation capabilities. Imagine you can automatically build jobs and configurations by combining different data sources with this runtime engine. You can use data from the internal database, your production systems or from external sources (via the API). First, the integrated, object-based REGai database lets you store any kind of information specific to your business function in a relational and vendor agnostic way. And then use them seamlessly with the REGai internal engine and smart templates to generate data-driven jobs and configurations. Simply create and modify services by updating the database and generate configs & jobs that you want provisioned to your network with just a single mouse click or API call. Second, imagine you can simply retrieve state information from your systems and use it dynamically in your jobs. This is what ‘command parsing’ scenarios are all about. It lets you send show commands to your applications and parse the requested information. The results can either be stored in the REGai database or used in real-time as input for your data-driven jobs. It gets even better when you learn more about ‘scenarios’.

Intent-Based Orchestration

By now you have the ability to generate and deploy data-driven jobs and configs to any of your applications. This is extremely powerful, but it does not solve the risk of spinning out of control when you allow ‘random’ design choices during implementation. This is the major factor causing systems to become inflexible, unstable and unnecessarily difficult to automate. In order to maximize your potential benefits, this needs to be resolved. Therefore, you want to be able to model and standardize your network services and changes. And enforce your design rules into every job, configuration and process you build. And all without losing any flexibility as described before. This is what ‘design modelling’ is all about. It allows you to build your own automation design and service models that can generate standardized (blueprinted) services, jobs and configurations and robotize your changes. Now you only need to ensure that these jobs get deployed without interfering with any existing service in your tools. This is done by using command parsing. Realtime state information is then validated at runtime to guarantee that existing services aren’t overwritten.

Multi-Vendor Support

Multi-vendor support expands on the initial cross-application workflow stage to incorporate REGai platform from more than one provider. Many businesses will not need this because they’ve standardized with one supplier. There will also be some businesses that have adopted a cloud-based product to run alongside. These building blocks are extremely powerful and can be used standalone, but the true power lies in combining them. You can build any automation solution you want as the possibilities are endless.

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.

Whether your goal is improving efficiency or cost reduction or increasing your current team capacity – Automate effectively with Measurable ROI


100% Cloud

Access at anytime, 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 here to support you. Medical device companies can choose to implement the entire RIM System or a few solution modules. REGai offers a modular approach ensuring you have a “fit-for-purpose” platform.

Simplified Pricing

REGai offers modular and simple pricing, so there are no surprises. All Cloud and you can add/drop modules anytime.


Integrate your existing Quality Management System (QMS) or ERP/PLM with REGai through pre-built connectors reducing implementation time and costs.

Ready to free up users from manual processes and save their time ?