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
Provides real-time dashboards for the management to visualize products submitted to / completed / pending / under review by regulatory agencies.
Establishes a streamlined approval process by enabling review and approval of responses to internal and external queries by corresponding leads.
Storing Queries and Responses
Enables storing the product related queries raised by agencies and respective responses given by regulatory team within the organization.
Facilitates management and tracking of the entire product lifecycle.
Sends notification to respective members if any queries are near their due date.
Keeps the product reviews, approval and product release on track.
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
Future-proof compliance, with seamless upgrades delivered over the cloud.
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.
Intuitive and easy to use UI (User Interface), ensuring a better ROI through faster adoption of the system.
Integration with QualZen™ to manage regulatory changes in associated SOPs efficiently, and with DocuZen™ to seamlessly compile information from multiple departments globally.