Technology that powers operational efficiencies

According to analysis by the Tufts Center for the Study of Drug Development, the average cost to develop and gain marketing approval for a new drug is $2.55 billion. A quarter of this cost is in content creation and meeting regulatory requirements.

Certara has developed leading technologies that save time and resources during the regulatory preparation and submission process, so you can get your therapeutics and medical devices to market faster.

As key opinion leaders, our regulatory technology specialists speak regularly at major industry events, including transparency and disclosure conferences, DIA meetings, PHUSE, and RAPS Regulatory Convergence.

Maximize your Data Fitness Score with Pinnacle 21

Pinnacle 21 offers a broad suite of solutions for your data needs: speccing, mapping, cleaning, checking, comparing, transforming, converting.

Validation: Analyze your data quality, see issues that affect FDA/PMDA review, and get insights into fixes with our leading engine.

Issue management: Delegate, fix, or explain issues across decentralized teams and sites.

Define.xml: Create 100% compliant Define.xml files with our intuitive, automated designer.

Reviewer’s guide: Advocate for your data and share their full context in our xDRG creator.

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GlobalSubmit eCTD 提交管理软件

Efficiently publish, validate and review electronic submissions.

  • GlobalSubmit PUBLISH 可实现更高效的文件和提交级别的发布和质量控制
  • GlobalSubmit VALIDATE 可帮助确保您所提交的文件在提交区域的技术有效性
  • GlobalSubmit WebReview 支持随时随地简化提交审查

GlobalSubmit CROSSCHECK 可以高效地对您的书签和超链接进行质量检查,不仅可以确保它们在技术上合格,而且可以让审查人在您的提交文件中找到正确的位置

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Synchrogenix eCTD 创作模板套件

We’ve paired our technical experts with our team of leading regulatory professionals to create a comprehensive eCTD authoring template suite. Based on our thirty plus years of planning, writing and publishing hundreds of global submissions, our template suite simplifies document creation and review and establishes a standardized approach to document development across different disciplines to ensure efficiencies.

  • 由监管专家维护的现行机构指南的指导性文本
  • 包含标准化快捷方式和符号的专用工具栏
  • 在整个过程中获得专家建议和技术支持

With toolbar features such as automatic formatting and easy table creation/conversion, our users spend approximately 50% less time on document formatting.

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Synchrogenix Writer

通过应用我们的专业和技术支持的服务交付,为您的安全报告提供助力。

减少完成大型叙述项目的时间,同时提供一致性。

  • Use Synchrogenix Writer’s narrative builder features to efficiently manage thousands of narratives to full completion, including review, in a fraction of the time
  • 可以使用预数据库锁定数据开发/测试模板,无需使用后数据库锁定数据进行额外操作
  • 加快遍历叙述集的速度并提高质量和一致性
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Engage with Patients via PODIUM

As a complement to our commitment to enhance engagement of patients, caregivers, clinicians, and patient advocates in drug development, we’ve created PODIUM. Using our secure PODIUM platform, sponsors can receive valuable responses throughout the clinical trial process from patient groups within specified therapeutic areas.

  • Inform protocol feasibility by engaging with patients in the study planning/development stage
  • Provide feedback on documents intended for patient use, including informed consent forms and patient summaries of EU Risk Management Plan

Allow patient groups an opportunity to provide comments and assess readability of the plain language summary

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Optimize your Medical Communications with BaseCase

Visualize your complex data, optimize medical communications, and create intuitive interactive apps – all without programming. Using Certara’s BaseCase platform, you can develop a range of content that presents key messages and outcomes in a clear and easy-to-understand way.

  • Engage your audience at congress’ & symposiums with dynamic and interactive versions of presentations and publications to maintain audience attention.
  • Educate your customers with relevant and tailored product information such as, clinical trial & plain language summaries, treatment pathways, and epidemiological research.
  • Communicate product value to key opinion leaders and stakeholders to ensure your product gets the right exposure, and to facilitate clear value-based discussions during meetings.
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Justin Savesky Sr. Director, Regulatory Science Technology

Justin has been immersed in the technology field for regulatory science for over eight years. He leads Synchrogenix technology commercialization efforts, including product strategy and management.

Gabriella Mangino Product Manager, Synchrogenix

Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.

Nirpal Singh Virdee Global Head of Transparency & Disclosure

Nirpal comes with over 18 years of Life Sciences experience. He is a subject matter expert in the Clinical Development, Regulatory Landscape, Transparency and Disclosure space. He is considered an industry thought leader, having globally presented at conferences. He has sat on industry advisory panels. At Synchrogenix , Nirpal is accountable for business development, client management and consulting for technology enabled services.

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