Transition to Regulatory Excellence
with ViSU

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ViSU™ is a cloud based Regulatory platform with modular approach designed specifically to enable global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building, publishing /QC automation & life cycle management), Document Authoring (Structured content or Word), HA/NB correspondence, Requests/Obligations tracking, UDI, Labeling Mgmt, eIFU. On top of these, a Global Reg Requirements database is included to help you get up-to-date requirements for product introductions or change impact assessments.

ViSU helps you embrace digitization and automation in regulatory that delivers collaboration and traceability leading to regulatory management efficiency, less compliance risks & cost reduction.

Your
Industry

An Effective Registration Tracking with detailed project management, workflows, alerts and more needed for established or emerging BioPharma companies. ViSU has these covered well.

With Built-in Reg Intel, for new regulatory changes do effective impact assessment in ViSU for faster decision making.

Document level publishing is fully automated saving lot of your time from archaic formatting, checks, linking and other manual tasks.

If you already use an eCTD publishing tool, we can complement it with either integration or tracking/linking files to different submissions for life cycle document tracking.
In most Generic and API manufacturing companies, with technology budget constraints (and sometimes teams not effectively communicating the need or business case of a Regulatory system to their management), Excel dominates and teams accept that unwillingly. With modular approach from ViSU, you can fit this to your budget and prove quantifiable benefits.

API manufacturers, In addition to their own HA tracking, they have customers (or Applicants) to deal with for document management and other obligations. ViSU handles these Upstream (customers) and Lateral (HA/Agencies) tracking and document management effectively.
Med Device companies’ regulatory needs are different and unique compared to BioPharma companies. With Distributors or partners in the mix, different functionality is needed to manage data and documents with 3rd parties.

For Device manufacturers, in addition to tracking all regulatory activities along with linking to right documents for better traceability, ViSU helps in building and publishing country specific Dossiers/Tech files with lot of automation built in. Also, leverage device specific modules like UDI, Standards (along with new/changes alerting) and eIFU based on your needs.
With a mix of products that fall into different categories (like OTC, Devices, Food, Cosmetics and more), definition of a “Product” is different for each category. This calls for a flexible system like ViSU to manage tracking and dossiers build part effectively.

Also with Built-in Reg Intel, always be on top of requirements needed in different countries to manage new product launches effectively and handle change control faster.
With a mix of products that fall into different categories, sometimes having a common system across portfolios becomes a challenge for Conglomerates with mixed portfolio of products. This calls for a flexible system like ViSU to manage registration tracking, data and documents effectively.

Also with Built-in Reg Intel, always be on top of requirements needed in different countries to manage new product launches effectively and handle change control faster.
Country-specific regulatory requirements database (120+ country specific regulatory requirements) that are updated daily. ViSU will alert you on upcoming changes (by business/functional area or by country) and link to products for effective impact assessment and focused alerts (with less noise).

Also included are Compliance (REACH, RoHS etc) requirements and Standard management as well.

You can opt for additional data sets like Global clinical trials DB, Global Labels DB (510K, USPI, SmPC etc. that are made searchable by extracting proper text from these documents).
Detailed information on Products captured and acts as a Central Repository for product information to serve as System of Truth. If you already maintain this info in other systems (like PLM, ERP), we have pre-built interfaces to manage push/pull to ensure system-of-truth is referred at all times.
With few clicks create new and manage life cycle of registrations in different countries. Intuitive project management attached to eliminate all excels or other tools for you to manage data, documents, and emails that relate to registrations and can be tracked by product, country, SKU, franchise and more.

For larger product launches, create programs and assign to different teams (or economic operators with limited access) for a truly global program management. With built-in alerting, you can ensure all obligations and renewals are done timely.
Comprehensive solution to support entire submission life-cycle, from planning, authoring, publishing to archival. Streamline end-to-end submission development, gaining visibility and painlessly. Built-in 100+ Country specific plans and applications (for FDA, EU, Canada, LATAM, GCC, and Asia) greatly reduce your “build/maintenance” time and also minimize risk of rejections or queries.

Track progress of dossier build through actionable reports and dashboards, mitigating risks to submission timelines. Publish submissions in zip or pdf or xml. Distribute through built-in cloud CMS (or push to your DMS) to internal or external stakeholders.
All Functional and Technical documents can be authored and maintained in ViSU. Choose between “Structured Authoring” or “Word” based authoring. All templates pre-loaded and helps reducing QC and manual formatting time by 80%.
Whether your source files are in WORD DOC or PDF, get submission ready files in SECONDS. With 300+ rules library, you pick and create your custom plans with flexibility of applying what/when to your documents on the fly. Save over 70% in time and costs.
RegBox is your regulatory Inbox (just like helpdesk ticketing systems). Manage all internal and external (like HA, NB, Agencies, Partners) requests and communication in a centralized module. This helps ensuring all requests are addressed timely without too many emails back-and-forth, excels and missing out through cracks.

In addition, automate all entries with built-in email extractor that pulls different emails and links to your products.
Prepare, Validate, Submit, and Track UDI Submissions of a product (initial &life-cycle). Product data gets converted and validated to different country requirements (presently supports FDA and EU EUDAMED).
Manage creation and maintenance of essential principles tables, allowing you to make bulk updates. Export in DOC or PDF formats to use in Tech Files/Dossiers. Using several workflows (you pick which is best for that product or franchise), cross-functionally to determine applicability, standards, and maintain compliance all the time. Get alerts when standards change by linking standards with your essential principles.
Subscribe for Medical Device Standards and get alerts or updates on subscribed standards. Maintain your standards copies in central repository. Link alerts to products for proactive risk management.
A modern Document Management System with all features included that acts as a central repository for all documents used in several modules of ViSU. If you already have EDMS, we can complement it with a link or do push/pull to ensure this EDMS compliments your system.
Web-based portal linked to products with internal and public web pages with several languages included. Access control, remote print and more to maintain full compliance.

Whether you are a Cost Center or
Strategic Unit, Execute effectively
with Measurable results

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