Regulatory Information Management System

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ReguZen™

AI/ML platform that facilitates high quality dossier compilation for submission. System that enables

Single review cycle approvals
Faster market access
Catering to various regulatory bodies

Check out our ReguZen™ Platform

Product Features

Real-Time Dashboard

Provides real-time dashboards which the management can use to visualize the number of products submitted to any particular regulatory agency, the number of products completed, pending and under review by regulatory agencies.

Approval Process

Enables review and approval by corresponding leads of responses submitted for queries.

Storing Queries and Responses

Enables storing the product related queries raised by agencies and respective responses given by regulatory team within the organization.

Product Lifecycle

Facilitates management and tracking of the entire product lifecycle.

Notifications

Sends notification to respective members if any queries are near their due date.

Product Tracking

Keeps the product reviews, approval and product release on track.

Impoved Efficiency

Increases speed, collaboration, efficiency and visibility across the entire global portfolio.

How ReguZen™ links with other ZenVector™ Products

ReguZen™ links with DocuZen™ and QualZen™ to ensure efficient dossier management
For submission to authorities, information needs to be collected from different departments and compiled in 1 dossier. ReguZen™ links with DocuZen™ within the ZenVector™ platform to compile documents from various departments, which all stored in one place
After product is approved and company gets marketing authorization, if any changes are to be made to the product, they are done through various quality events, like CCN, Incidents etc. This again needs to be sent to the authorities through a fresh dossier. ReguZen™ links with QualZen™ to compile all the required information within the ZenVector™ platform, thereby ensuring a comprehensive dossier

Product Differentiators

Future-proof compliance

Future-proof compliance, with seamless upgrades delivered over the cloud.

Built-in automation

Built-in automation and workflow simplification to make regulatory operations faster and more efficient.

Single Integrated Application

Single integrated application to plan, track and execute all global regulatory activities, leading to Faster Market Access.

AI/ML and NLP Capabilities

AI/ML and NLP Capabilities.

Better ROI

Intuitive and easy to use UI (User Interface), ensuring a better ROI through faster adoption of the system.

Integrations

Integration with QualZen™ to manage regulatory changes in associated SOPs efficiently, and with DocuZen™ to seamlessly compile information from multiple departments globally.