Understanding the Evolving Role & Responsibilities of the Regulatory Affairs Professional
View the results of a survey of 200 Regulatory Management leaders from regulated industries such as consumer goods, cosmetics, food & beverage, specialty chemicals, and crop science. Report findings reveal insights into the opportunities and challenges facing regulatory practitioners in 2021 and beyond.View the Report
Don't waste time looking for documents and data with Regulatory document Management, an intuitive, fit-for-purpose collaboration system that gives you efficiency, transparency, accuracy and security.
End-to-end regulatory compliance begins with supplier transparency. With Veeva RegulatoryOne, you can safely and securely include Suppliers in your regulatory processes and eliminate emails and missed deadlines.
Respond to customers with speed and accuracy using Regulatory Request Management. Workflows and automation drive efficiency, and dashboards provide transparency and KPIs that unlock new insights and opportunities.
RegulatoryOne’s registration capabilities manage product registration and third party certification 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, country, and/or distribution channel.
"Users are coming up with their own ideas of how they can make minor improvements to processes. 'If we could just alter that field, or include this field.' Configuration is so easy that I can do it myself, it's done within a couple of minutes, and we can make incremental changes to keep our users happy and increase adoption. They've also come up with a lot of bigger ideas for moving some of our other processes into our Veeva Vault."
Shanna Chriscoe, Business Lead, Syngenta
"Veeva allows us to centralize the end-to-end process of registering genetically-modified products, as all of the applications are unified on one platform. Users can now seamlessly exchange information, and re-use content. Also, we've integrated with Planisware [portfolio management software], to reduce data entry duplication, and increase quality of information across systems."
Shanna Chriscoe, Business Lead, Syngenta
"Nufarm markets crop protection products in more than 100 countries. So it is a tough and yet very important task to comply with increasingly demanding regulatory environments around the globe. We were looking for an easier way to manage all related data and content and found Veeva RegulatoryOne - a single, authoritative solution for all our compliance and regulatory needs. Their solution maturity and engagement impressed us."
Ray Hamilton, Head European Regulatory Lead, Nufarm Europe GmbH
Documents are the lifeblood of regulatory communication, and a transparent, secure, single source of truth for global documents is a critical foundation and enabler of speed, efficiency, and accuracy.
RegulatoryOne provides powerful document control features including “google-like” search, version control, audit trails, document templates, workflow approvals, and collaboration tools that maximize communication, compliance, and efficiency.
This approach enables:
RegulatoryOne Document Control provides a pre-configured repository for your important documents including SDS, RDS, RMQs and Studies. It is also pre-configured to simplify indexing and managing end-point study documents in context with study data and formulas.
Veeva RegulatoryOne puts your regulatory documents into true relational context with data providing a unified, transparent system of record for regulatory collaboration and knowledge.
Increasing customer and consumer demands for transparency are driving exponential growth in product stewardship and regulatory data requests.
RegulatoryOne simplifies and tracks the initiation, assignment, and response to requests from stakeholders. Workflow automation and a powerful, integrated document and data library simplifies and unifies regulatory knowledge. Real time KPI’s and dashboards enable agility and unlock fresh insights.
RegulatoryOne Compliance Management brings you closer to your customers and suppliers through the use of collaboration tools, the support of continued evolution from document compliance to data compliance, and is an enabler for product and raw material selection and insight.
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.