Velocity to market: Today’s market forces demand that companies stay agile and responsive to meet regulatory changes and customer expectations. From quickly assessing the impact of a proposed product or formulation change, to locating the substantiating and source documentation, and finally coordinating activities on a global, regional and local basis, RegulatoryOne has you covered.
Reliable data quality: Create a single source of truth for your product portfolio by capturing timely and accurate information. Information and content is stored once and can be accessed globally. This ensures data integrity as you coordinate product release processes across your stakeholders.
Global coordination & alignment: As a cloud-based software solution, RegulatoryOne seamlessly orchestrates compliance related activities across manufacturing sites, supply chains, outsourced manufacturers and all internal stakeholders. Product information is accurate, timely and accessible throughout the entire product lifecycle.
RegulatoryOne’s registration capabilities manage product registration information globally and is accessible by both internal and external parties at any time. Achieve a single, unified view of product data by registration status, by market, by variation and maintain communication with regulatory bodies.
RegulatoryOne provides quick insight on formula compliance with visual indicators of compliance for each ingredient. Ingredient restrictions are imported from regulatory lists, third party providers, or even internal brand standards or retailers, to create customized compliance standards for your products. Formula Insights capabilities enable compliance at a quick glance and replaces tedious manual processes.
RegulatoryOne automates the planning, collection, review and approval of all product related content, prior to submission. This includes submission-ready documents, dossier