Assure and accelerate a successful regulatory submission
Partner with our team of expert regulatory operations specialists and publish with our proven eCTD software
Electronic Common Technical Document (eCTD) is the standard format for regulatory submission to many worldwide health authorities. eCTD format is required for submissions ranging from investigational applications to marketing authorizations, and all lifecycle management documentation in between (such as amendments, supplements, and annual reports). The International Council for Harmonisation (ICH) introduced eCTD formatting requirements for health authorities including: FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER); EMA, MHRA, Swiss Medic, TGA, and Health Canada.
eCTD publishing can be complicated and costly, especially as regulatory agencies require even more submission-types in electronic formats. These include eCTD submissions in support of New Drug Applications (NDAs), Marketing Authorisation Applications (MAAs), New Drug Submissions (NDS), Investigational New Drug (IND) applications, and many more. In addition, maintaining compliance will be increasingly difficult as regulatory requirements and mandates change across markets.
Certara Synchrogenix provides the services to help avoid common issues that can lead to submission rejections by partnering with a team of experts who have a proven track record of success in regulatory submissions, compliance, and eCTD management software.
Certara Synchrogenix ensures efficient, timely submissions through our GlobalSubmit eCTD software and our experienced team of regulatory operations and eCTD publishing specialists.
Whether you are seeking a full-fledged regulatory operations consultancy to act as your department, a provider for occasional overflow support, or licensable eCTD software solutions, Certara Synchrogenix offers partnership models customized to meet any and all of your needs.
Anticipating challenges helps accelerate submissions and mitigate risks of costly delays
A provider with deep knowledge in regulatory submission process enables fast response to changes in regulatory requirements and mandates
- 如期或提前完成申报
- Maximize re-use of content and minimize additional costs for submissions to additional global agencies
- Mitigate the risk of errors and costly delays
- Avoid rework by generating compliant, validated submissions the first time
- Internally review and approve submissions easily and efficiently
- Know where your submission is in the publishing process at all times
信任专家
我们的专家都拥有深厚的监管知识，凭借数十年的申报经验，可对每一个新的强制性命令和要求变化做出及时响应。
作为重要的思想领袖，我们的监管运营专家经常在重要的行业活动上发言、与各种监管组织合作，并通过博客和网络研讨会分享我们的知识。
Check out our latest regulatory operations blog posts:
GlobalSubmit eCTD 提交管理软件
Our regulatory operations specialists consult with your team, utilizing easy-to-use eCTD software needed to efficiently publish, validate, and review regulatory submissions.
- GlobalSubmit 发布 — 发布适用于各个卫生主管机构的符合监管要求的 PDF 申报文件
- GlobalSubmit 验证 — 评估您的 eCTD 申报文件的技术有效性并消除技术上造拒的风险
- GlobalSubmit Web 审阅 — 协助各利益相关方及时审阅您的 eCTD 申报文件
GlobalSubmit eCTD 申报管理软件可以作为解决方案提供，也可以通过我们的监管支持服务提供。
支持向主要全球机构提交申报文件
- 上市申请申报：NDA (New Drug Application), ANDA (Abbreviated New Drug Application, sNDA (Supplemental New Drug Application), BLA (Biologics License Application, MAA (Marketing Authorisation Applications), NDS (New Drug Submission)
- 新药临床试验和主文件申报：IND、DMF、ASMF
- 生命周期维护提交
- 主文件提交
- 美国代理服务
- 电子传输
- 监管咨询
我们支持在全球范围内向 FDA、EMA、MHRA、Swiss Medic、TGA 和加拿大卫生部监管机构提交申报文件。Our team also provides US Agent support to sponsors who need an authorized U.S. Agent to interact with the FDA on their behalf.
Maryanne 是一位成就卓著、以结果为导向的监管事务专业人士，擅长 eCTD 提交、FDA 互动和项目管理。她拥有20多年的工作经验，在向各种监管机构成功提交监管申请方面成绩斐然。
Maryanne 是一位成就卓著、以结果为导向的监管事务专业人士，擅长 eCTD 提交、FDA 互动和项目管理。她拥有20多年的工作经验，在向各种监管机构成功提交监管申请方面成绩斐然。
