DDi LLC
Model ViSU - Cloud Based Regulatory Information Management Software
FromDDi LLC
ViSU™ is a cloud based Regulatory platform with modular approach designed speci?cally 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.
Most popular related searches
BioPharma
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.
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.
Generics/API
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.
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.
Medical Device
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.
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.
Consumer Health
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.
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.
Mixed Portfolio
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.
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.
- 100% Cloud : Access at any time, from anywhere using secure private cloud. ViSU is a single source for information and implementation enables you to focus on execution and compliance.
- Scalable : Whether you`re a small-midsized business focusing to become a global company or already have a global presence, we are ready. Companies can choose to implement the entire RIM System or few solution modules. ViSU offers modular approach ensuring you have "fit-for-purpose" platform
- Simplified Pricing : ViSU offers modular and simple pricing, so there are no surprises. All Cloud and you can add/drop modules anytime.
- Integrations : Integrate your existing Quality Management System (QMS) or ERP/PLM with ViSU with pre-built connectors reducing implementation time and costs.