Writing
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
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.
Submissions
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.
QC
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.
CMC
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
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.
100% Cloud
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).
Scalable
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.
Simplified Pricing
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.
Integrations
Integrate your existing EDMS or RIM or Quality systems with REGai with pre-built connectors reducing implementation time and costs.