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.

Based on the importance and high cost, Certara Regulatory Science, also known as Synchrogenix, has paired technology to your needs to develop solutions that save time and resources so you can get your therapeutics to market faster.

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

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

Synchrogenix eCTD 创作模板套件

我们将我们的技术专家与我们在监管程序和监管写作方面的合格专业人员团队搭配一起,根据他们 30 多年在规划、写作、编辑和发表数百份全球提交件方面的经验,创建了一个综合的 eCTD 创作模板套件。


  • 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

借助于工具栏的功能,如自动格式化和简单的表格创建/转换,我们的用户在文档格式化上所花费的时间减少了大约 50% 以上。

Synchrogenix Writer

Power your safety reporting by applying our experts and technology-enabled service delivery.

Reduce time to completion of large narrative projects while providing consistency.

  • Our experts engage Synchrogenix Writer’s narrative builder features to efficiently manage thousands of narratives to full completion, including review, in a fraction of the time
  • Templates can be developed/tested with pre-Database Lock data with no additional work required using post-Database Lock data
  • Gain speed, quality, and consistency across your narrative set
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

Optimize your Medical Communications

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.
Download the Brochure
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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