重新构想监管服务交付
保持今天的复杂，不断变化的监管要求需要不同的方法。专家资源。简化过程。领先的技术。必威官方在线伙伴的文化。IQVIA综合的全球监管事务专家团队旨在支持您从早期开发到提交及以后的旅程。
Lower your administrative burden across the complete product lifecycle
Our Global Regulatory Affairs team helps biopharma and medtech companies handle regulatory workflows more flexibly, productively and efficiently. From strategic regulatory advice to regulatory maintenance and lifecycle support, we’ve got you covered. IQVIA’s expert resources, streamlined processes and leading technologies provide:- Optimized time to key decision points
- 监管和运营风险缓解
- 简化的监管途径
- Flexible approaches to generating more informative evidence earlier
- 提高透明度和主动解决问题
Drive strategy through expert insight and advice
Industry-leading therapeutic and functional area experts help clients glean relevant regulatory insights from world-class data, enabling real-time determination and evaluation of time, cost and risk. Our integrated consulting approach can also provide both program- and study-level strategy including realistic asset valuation. Learn more about our capabilities in
- 缺口分析
- 监管计划策略
- 创新的监管路线图
将您的产品保持在正确的轨道上
以更高的准确性，敏捷性和效率来导航不断变化的监管需求。让我们在最需要的地方帮助您。我们1900多个经验丰富的监管事务专业人员准备在65个以上的全球地点提供整个产品生命周期的任何地方。
- Health authority regulatory submissions - authoring and publishing across all drug development programs
- US agency/health authority liaison on your behalf
- Regulatory intelligence - real-time access to current requirements for 110+ countries and organizations
- Lifecycle maintenance - license extensions, writing, labeling, marketing authorization transfers, CMC change requests
- 孤儿病，再生医学，高级和突破疗法，儿科，适应性途径等领域的专业名称
使用技术支持服务简化密钥工作流程
Our worldwide hubs provide “follow-the-sun” submission management and publishing capabilities across the globe. Decades of experience managing electronic and paper dossiers assure speed, efficiency and quality at high volume.
- Lifecycle publishing
- 派往卫生当局必威手机APP
- 轮辋数据维护
- Submission-ready document preparation
- 技术格式
iqviaRIM Smart. Intelligence, automation and integration.
提高您的监管生产率。
自动化和标准化您的监管管理，从对登记和跟踪的信件和承诺。