常见问题

Find answers to common questions about our services, products, and policies.

二十八 FAQs found

安全性与合规性

RegASK 是否符合数据隐私和安全标准?

RegASK is GDPR-compliant and certified under internationally recognized standards, including ISO 27001 and SOC 2 Type 2.

All data are encrypted in transit and at rest, access is strictly role-based, and the platform is hosted on secure Microsoft Azure infrastructure.

For Life Sciences clients, RegASK aligns with GxP and other relevant industry-specific security frameworks where applicable.

关于RegASK

RegASK 如何帮助监管团队?

RegASK 减少 手动工作并加快上市时间, ,提高效率、准确性和商业价值。.

我们的人工智能驱动的监管智能平台可自动监控全球法规、提供可操作的见解并提供后续步骤的指导。.

这意味着监管团队可以减少搜索和整理数据的时间,从而将更多时间用于制定战略决策。通过简化合规工作流程,RegASK 可以帮助企业 保持领先于监管变化,更快地推出产品,并自信地扩展到新市场。.

用例和优势

RegASK 解决了哪些监管问题?

RegASK 消除了人工监管监控、碎片化工作流程以及缓慢的上市速度。该平台利用人工智能驱动的监管情报和代理来:

– Reduce manual work by automating global regulation tracking and change detection
– Stay ahead of changing global regulation
– Cut uncertainties with actionable insights and next-step guidance
– Break information silos by centralizing requirements, evidence, and decisions
– Lower compliance risk and costs through continuous monitoring and audit-ready traceability
– Scale to new markets faster with localized, multi-country coverage
– Improve audit readiness and documentation

结果是:发布速度更快、可预测性更高,监管团队专注于战略而不是重复性任务。.

平台和技术

How does RegASK's AI engine work?

RegASK’s AI-driven engine, RegGenius, is built on vertical, domain-specific models that:

– Continuously monitor global regulatory updates with timely, curated intelligence
– Automate workflows and streamline end-to-end regulatory operations
– Summarize and translate local regulations into actionable insights
– Support regulatory pathway analysis and generate draft documents

Powered by a multi-agent architecture, RegGenius performs Q&A, summarization, and document analysis in parallel enhancing both speed and precision.

关于RegASK

Who are RegASK's typical customers?

RegASK 专为跨 监管事务、合规、风险管理、质量保证和药物警戒。.

RegASK 为监管事务、合规与风险、质量和药物警戒团队提供智能文档、精选警报和可操作的见解。

RegASK 支持组织 生命科学和消费品 通过简化工作流程和提供及时的见解来保持领先于全球监管变化。.

开始使用 RegASK

如何开始使用 RegASK?

You can request a demo or speak with our sales team by visiting the Contact Us page or booking a demo.

安全性与合规性

RegASK如何确保数据安全性和保密性?

The platform is hosted on secure cloud infrastructure, complies with GDPR and follows best practices for data protection. Confidential client information is safeguarded through encryption and strict access controls.

This ensures that sensitive regulatory and product data remain protected while teams benefit from automation and intelligence.

平台和技术

什么是监管AI代理?

A regulatory AI agent is a specialized, AI-driven software system designed to perform key compliance tasks such as:

– Monitoring and interpreting timely regulatory updates
– Answering compliance-related questions
– Assisting with regulatory submission planning and deadline tracking

RegASK leverages a multi-agent architecture to deliver contextualized support across the regulatory lifecycle. RegASK enhances decision-making, reduces manual effort, and accelerates time-to-market.

用例和优势

RegASK 是否支持区域、多语言监管合规性?

RegASK 支持多语言和区域监管需求。.

RegASK’s AI-driven engine offers instant translation in 120+ languages and delivers localized insights tailored to specific markets, including United States, Canada, South America, EU, UK, APAC (Japan, China, South Korea, Australia, Singapore etc) and GCC.

关于RegASK

RegASK 服务于哪些行业?

RegASK 服务于受到严格监管的两个行业,即生命科学和消费品,包括:

生命科学
– Pharma, BioPharma & Biotech
– Consumer Health
– Medical Devices & Medtech
– CRO

消费产品
– General Food & Beverage
– Dietary and Health Supplements
– Infant Formula and Food for Special Needs
– Food Ingredients
– Animal Health and Nutrition
– Cosmetics and Personal Care
– Hygiene and Haircare
– Beauty Devices
– Oral Health

定价和访问

RegASK 的定价是多少?

RegASK’s pricing is tailored to each customer’s needs. To receive a customized proposal, please contact our Sales team.

支持和客户成功

How does RegASK's Customer Success team ensure ongoing regulatory support?

RegASK’s Customer Success team partners with clients from day one, starting with a strategic kickoff to align goals and challenges. We ensure fast onboarding with credentials shared within an hour and a calibration session within 30 days.

We drive ongoing value through monthly touchpoints that track adoption, progress, and share updates on new features, supported by training resources and videos. Clients also have access to a robust self-service help center and responsive ticket-based support, ensuring seamless and confident platform use throughout the partnership.

用例和优势

RegASK 能取代监管专家吗?

No, RegASK does not replace regulatory professionals. It augments their capabilities and empowers them.

该平台可实现人工监控自动化,追踪全球监管变化,并提供切实可行的洞察,使监管团队能够专注于更高价值的工作。最终,在人力专业知识和智能自动化的共同驱动下,实现更智能、更快速的合规。.

监管团队无需花费大量时间执行重复的合规任务,而是使用 RegASK 来加快上市时间表、降低合规风险并做出更快的基于证据的决策。.

关于RegASK

监管团队可以通过 RegASK 获得什么样的投资回报?

RegASK 交付 可衡量的投资回报率 通过减少 合规成本、最大限度地减少延误并加快产品审批。. 客户报告称,自动监控节省了大量时间,加快了监管情报的周转速度,并提高了产品发布的成功率。.

通过避免延误和合规风险,组织看到 更高的利润率和更快的市场进入速度。.

认可与合作

RegASK 是否已获得分析师的认可?

Yes, RegASK has been recognized by leading industry analysts. In 2024, RegASK was featured in the Gartner Market Guide for Regulatory Intelligence Solutions, the first key industry report reviewing top vendors in the emerging regulatory intelligence software space.

This report highlights the capabilities required for effective regulatory intelligence and underscores the growing demand for AI-driven solutions to manage complex regulatory changes.

RegASK’s inclusion demonstrates its strength in:

– Content curation and aggregation
– Regulatory change management
– AI-enhanced insight delivery

支持和客户成功

如果我需要平台之外的监管专业知识怎么办?

RegASK offers on-demand access to regulatory experts through its Ask RegASK service, available directly via the platform. You can engage our experts through an annual subscription to extend your team’s capacity or as an ad-hoc service alongside your platform subscription.

Our team can help you customize the level of expert support to match your regulatory strategy, timelines, and regional priorities.

支持和客户成功

RegASK 是否提供入职支持?

Yes, RegASK’s Customer Success team delivers customized onboarding that emphasizes platform enablement and aligns use cases with feature adoption to resolve identified pain points.

关于RegASK

RegASK 如何改善监管工作流程?

RegASK 集成 将智能融入现有工作流程,, 因此,洞察信息将直接传递到监管、质量、药物警戒和产品团队手中。仪表盘和警报功能确保更新具有可操作性且优先处理。.

这创造了 跨职能效率 和 减少瓶颈 产品发布缓慢。.

认可与合作

Who are RegASK's key technology and distribution partners?

RegASK is proud to partner with technology partners such as AWS, NVIDIA, and Google, reinforcing our AI-driven approach to regulatory intelligence and workflow orchestration.

We also collaborate with trusted distribution partners, such as Matsumoto in Japan, to expand global reach and deliver localized regulatory support.

支持和客户成功

RegASK 是否为团队提供培训?

Yes, in addition to onboarding sessions, RegASK’s Customer Success team proactively shares updates on new product releases and capabilities, providing training materials and videos to help your team leverage enhanced functionality as it becomes available.

定价和访问

RegASK 是否提供免费试用或试点?

RegASK 不提供免费试用。我们的大多数客户通过年度订阅的方式部署 RegASK;然而,在某些情况下,我们可能会在全面部署之前讨论试用事宜。.

认可与合作

RegASK 获得过任何奖项或认可吗?

RegASK has been recognized as a leading company in the AI RegTech space. We have been featured in the and named as one of the Top 50 Thought Leading Companies for Generative AI 2025. We’re also honored to be recognized for the second consecutive year as one of the Top 50 Thought Leading Companies on Artificial Intelligence by Thinkers360.

定价和访问

有哪些订阅模式?

RegASK 采用基于年度订阅和覆盖范围的混合定价模式。.

认可与合作

Where has RegASK been featured in the media?

RegASK has been featured in major industry publications and media outlets, including The Wall Street Journal and Bloomberg.

定价和访问

有学术或 SME 套餐吗?

是的,我们提供中小企业套餐。.

认可与合作

How have RegASK's leaders been recognized for their contributions to regulatory intelligence and compliance?

RegASK’s leaders have been honored for their impact in the AI and compliance ecosystem. Caroline Shleifer and Amenallah Reghimi were also recognized as 2025 Pros to Know by Supply & Demand Chain Executive, highlighting their expertise and thought leadership in the regulatory intelligence space.

认可与合作

RegASK 参加哪些行业活动和会议?

RegASK regularly participates in industry conferences such as RAPS Convergence.

You can check out our section “News” to learn more about our latest and future events.

关于RegASK

RegASK 是谁?

RegASK 是领先的 人工智能驱动的监管情报和工作流程编排平台, 为高度监管领域的全球组织提供支持,包括 生命科学和消费品, ,积极应对复杂的监管环境。.

利用 GenAI 和高级 Agentic AI,, RegASK 提供主动监控、可操作的洞察和端到端工作流自动化,简化合规流程,降低风险,并加快上市时间。 150多个国家。. 我们推动效率、准确性和商业价值。.