Regulatory Information Management Software

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

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.

Medical Device

Med Device companies’ regulatory needs are different and unique compared to BioParma companies. With Distributors or partners in the mix, different functionality needed to manage data and documents with 3rd parties.

For Device manufacturers, in addition to trackingall 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.

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.

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.

Chemical

Chemical registration management and maintenance is unique and challenging. Though nomenclatures are standardized (like with CAS numbers etc) globally, product relationships from Regulatory perspective (not the same that’s in ERP systems) are unique to each company. Registration aspects in different countries are governed by separate agencies (like EPA) and to complicate, local registrations needed as well in addition. Claims, test results, label information and other parameters to be linked and managed for each registration.

Mixed Portfolio

With a mix of products that fall into different categories, sometimes having a common system across portfolio 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

Execute your company strategy and accelerate global product registrations, submissions and tracking

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Move Fast

Accelerate time to market by better business process integration to plan, execute, and track all global regulatory activities in a single, integrated RIM application, with continuous access to regulatory documents and full support for global regulatory submission requirements to speed-up health authority submission timelines. Built-in automation streamlines workflows to reduce administrative burden and provide greater confidence in product registration data quality.

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Reduce Regulatory Risk to Future-Proof Compliance

Reduce risk and stay compliant with the latest regulatory requirements with a built-in Reg Intel that keeps you up-to-date in real-time. Create and assign regulatory tasks across your organization – for management, departments, headquarters, and affiliates.

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Simplify the Regulatory Lifecycle

Manage the entire regulatory lifecycle in a single platform with intuitive, ease to use user interface, for faster adoption and better ROI. Streamline planning and tracking of interactions, commitments and obligations, as well as document and dossier management, publishing, reporting, and data standards compliance with our alert management system. Integrated reports and charts support management’s overview of critical renewal dates, current ongoing activities, and finalized tasks completed in the last few months.

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Reduce Manual Efforts with Smart Forms & Automation

Add efficiency without losing control by automating manual workflows including intelligent task assignment, submission planning, and performance tracking and increase connectivity for improved efficiency, decreased costs, better coordination and cross-enterprise visibility. Our pre-configured templates help expedite regulatory submission and dossier planning. Automatic notifications help you to inform the assigned users about new tasks or send reminders before due date

Reg Intel (Global requirement live DB)

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).

Product Master

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.

Registrations & Tracking

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.

Tech Files / Dossiers

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.

Documents Authoring

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%.

Publishing Automation

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

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.

UDI

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).

GSPR (Essential Principles)

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.

Standards

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.

EDMS

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.

eIFU/Labeling

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

Automation at its Best: Only RIM with full automation of your documents (formatting, QC, Pre-publishing). In addition, automate your workflows, dossier, and submission planning to minimize compliance issues and increase speed

360° Visibility: Seamless transitions between Regulatory Affairs, Regulatory Operations, HQ, and Affiliates

Progress Tracking: See real-time progress status, key dates, and deadlines in one solution via dashboards

ViSU
Benefits

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.

Ready to improve your efficiency and lead the regulatory function "better" ?

Transition to Regulatory Excellence with ViSU

Your Industry