- What is RegulatoryOne?
- What is Regulatory Information Management?
- Who is it designed for?
- Is RegulatoryOne a NEW product?
- What are common use cases for RegulatoryOne?
- How is it licensed?
- How can I learn more?
What is RegulatoryOne?
RegulatoryOne unifies and coordinates all facets of the regulatory process, providing you with visibility into what you’re selling, when you can sell it, and where it’s being sold – all in one place. This pure cloud offering replaces bespoke, manual systems with a single, authoritative solution for all your compliance and regulatory needs, providing you with the agility to respond to changing regulations. These efficiency gains improve your time to market, while providing transparency across your entire organization with each product release gate that a product passes through on its way to market.
What is Regulatory Information Management?
Regulatory Information management encompasses the work done by regulatory affairs departments to secure and maintain regulatory compliance to ensure their products are approved for sale within a given region. RegulatoryOne provides transparency to various product stakeholders who can track compliance issues throughout the product life cycle.
Examples of some typical regulatory activities include:
- Applying for approval to sell a product in a new country or region.
- Correspondence with regulatory authorities to maximize the likelihood of approval.
- Project-managing the contributions from other departments for each regulatory submission.
- Ensuring all necessary information is submitted on time and in the correct format.
- Registering products and maintaining accurate records of all product information throughout the product’s lifecycle.
- Submitting an annual report for each product, providing information from the previous year regarding the distribution, safety, effectiveness, and labeling of the product.
- Managing all post-submission interactions with regulatory authorities (responding to questions, fulfilling commitments).
Who is it designed for?
RegulatoryOne is designed for organizations challenged with registering products across multiple product families and geographies while remaining compliant with specific product, industry and country-specific regulations.
What problems does RegulatoryOne solve?
If you have challenges answering the following questions, then RegulatoryOne is something that you should consider:
At the end of the day, it’s all about getting to market fast! 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.
Is RegulatoryOne a NEW product?
Veeva has a long and proud tradition of providing “fit for purpose” applications for the life sciences market. To date, Veeva has over 25 applications, tailored for the specific needs of our life sciences customers. We are taking the same approach for both the consumer goods and chemical markets. RegulatoryOne is a direct, derivative of Veeva’s RIM offering. So, you’re certainly not the first to implement this solution. In fact, we have one consumer goods company, leveraging RegulatoryOne for roughly 10,000 product registrations.
What are common use cases for RegulatoryOne?
- 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 automates the planning, collection, review and approval of all product related content, prior to submission. This includes submission-ready documents, content planning and tracking, correspondence, product claims commitments and submission records. RegulatoryOne’s submissions capabilities provide you with full traceability for all your regulatory activities.
RegulatoryOne Submission Publishing
- RegulatoryOne publishing capabilities simplify your final product submission by alerting you to issues that you can proactively address during the authoring process. This continuous publishing process provides greater visibility and speed throughout the product release process and allows you to more dynamically respond to changing regulations across the markets you serve.
RegulatoryOne Submission Archive
- Provides a single source of truth and a complete archive for all your regulatory submissions. Imagine simple browser access to all your product submission components for authorized internal and external stakeholders to both use and reuse in local markets.
How is it licensed?
As a multi-tenant, cloud-based SaaS provider, Veeva offers flexible pricing options. Our standard model is User-Based pricing. The Veeva pricing approach is straightforward, predictable and easy for customers to understand; as users are added cost will increase.
This model is great for most organizations, but we realize that this model becomes less attractive as our customers scale to thousands of users. To address this, Veeva offers an Enterprise License pricing model that is a single, annual subscription fee for the use of an application(s) and is managed by a governor vs. per-user cost. This model ensures pricing is tied to the right incremental unit of value for our customers in consideration of engagement at an enterprise level.
For specific pricing information, please contact us and one of our specialists will be happy to provide a quote based on your specific business requirements.