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法规Support for Endocrine Disruptors
内分泌破坏器（ED）测试不仅仅是关于科学敏锐，研究执行和卓越的研究。监管洞察力是至关重要的，因为它指导您通过法律复杂性和证据解释，因此您可以创造令人信服的论据，以证明您的物质对监管机构的潜力。
Covance has the acumen and experience to address complex regulatory questions and ease the passage of your substance through its regulatory journey.
- Covance provides pragmatic advice to smooth the regulatory passage of your substance through the regulation with minimum effort and outlay
- Extensive insight and experience in ED regulatory processes in major markets allows us to anticipate and avoid potential issues occurring
- 法规expertise going beyond advice: as your partner we can draft regulatory submissions, respond to questions, and represent you at hearings using clear and robust regulatory arguments
Your Needs
内分泌干扰者的监管环境在全世界各不均匀，正在发展
世界各地的监管环境在评估内分泌干扰潜力的方法方面有很大差异很大。如果您的物质在多个市场中销售，则需要一个ED数据集和学习程序，可以跨监管环境有效地利用。但它很难确定您的物质的正确监管策略。您希望优化现有数据，学习效率和成本效益，而不会危及监管成功。这意味着利用你已经拥有的东西，并对设计测试方法和采用数据豁免做出一些艰难的决定。
我们的能力
Creating compelling weight of evidence arguments based on published data, QSARs and read across
Leveraging the existing information on a substance is the foundational step in building your regulatory strategy. Our regulatory scientists conduct literature searches in line with mandated standards to build a robust evidence base from published data. Combining this with QSAR modelling and read across, we can build compelling arguments that may enable avoid additional testing. The weight of evidence approach is also used as a primary strategy when preparing the argument for or against a test item being classified as an endocrine disruptor or not.
将ed提交给监管要求
全球法规变化，了解如何解释不同监管机构的要求对成功至关重要。通过跨监管机构的专业知识和对ED端点的深入了解，我们的团队能够得到很好的定位，以帮助您通过任何监管障碍。从战略咨询有关如何优化法规成功的，为豁免构建科学理由，或汇集全面的档案，景气可以提供一系列服务以满足您的需求。