确保最高质量的文件
上市申请所需的监管文件类型繁多而复杂。由于这些文件代表了许多不同的学科以及对药物开发至关重要的多年研究和数据，监管审查人员要求文件以特定的内容和格式编写。手动文件管理流程和不同的系统造成了巨大的低效率，因为申办方们需要努力解决这些问题：
- Maintaining version control of documents
- Changing regulatory requirements
- Handling document review and approval processes
These inefficiencies may lead to submission delays, increased costs, and the risk of nonacceptance of your submission.
A comprehensive, process-driven document quality and management program will provide assurance that your regulatory documents are compliant and of the highest quality. While Synchrogenix writing teams support content creation, editorial teams are available to manage document management processes.
Synchrogenix’s document quality and management team of regulatory writers and technical editors assures the efficient and effective management and review of your regulatory documents. All of Synchrogenix’s quality control (QC) qualified staff undergoes thorough training, including objective assessments and peer review, to qualify as a QC reviewer. Lead technical editors act as project managers and provide leadership and oversight for all QC-related activities for a client.
Over the past five years, Synchrogenix’s document quality and management team have QCed over 6,700 CMC, nonclinical, and clinical documents that contributed to successful regulatory submissions for sponsors.
Industry Best-in-Class SOPs Drive Quality and Compliance
Synchrogenix’s team does not wait until the end of the document development process for quality review. Our team implements quality processes early and at several steps in a document’s lifecycle.
Industry best-in-class SOPs and training establish high standards, while dedicated global in-house QC staff accommodate compressed timelines without compromising overall quality. Effective communication tools that define and specify expectations are supported by:
- Utilizing effective templates
- Developing a Style guide
- Agreeing on consistent messaging
Creation and use of these tools allow our QC teams to efficiently and effectively review documents to ensure:
- Alignment to source documents
- Consistency of presentation
- Consistency of grammar
This ensures delivery of a quality final draft that is compliant with regulatory expectations and regulations.
A Single Point of Contact Across Regulatory Documents for Maximum Efficiency
An established, consistent, single point of contact leads our cohesive review team of highly qualified editors. This lead technical editor coordinates activities across one or more regulatory documents to maximize efficient and effective review.
Lead technical editors are also your:
- Microsoft Word guru
- Point of contact for QC-related projects
- Document management expert
- Style and editorial preferences overseer
Our lead technical editors also support formatting services to work with your writing team to ensure delivery of eCTD compliant documents to our in-house document-level publishers or your regulatory publishers.
GlobalSubmit eCTD 创作模板套件
我们将技术专家与我们的监管作家和编辑配对，以创建全面的 eCTD 创作模板套件。我们的模板已预先加载：
- 专用工具栏
- 正确格式
- 文件粒度
- 隐藏文本中提供专家意见的机构特定指南
- 指导申办方进行成功提交的最佳实践
Our lead technical editors are experts on how to use and troubleshoot our template suite and are versatile enough to support other template suites.
我们的创作模板是监管作家根据计划、撰写和编辑数百份全球提交文件的数十年经验为监管作家创建的唯一模板。
Flexible and Scalable Resource Pools
Approximately 100 full-time QC-qualified staff (some ELS certified) are located throughout North America, Europe and Asia-Pacific, allowing for round-the-clock support and the flexibility and scalability required for rapid response to your compressed timelines.
我们的团队
Dawn Guyer Synchrogenix 文件质量总监
Kristen Brotzman, ELS高级监管服务经理
Dawn Guyer Synchrogenix 文件质量总监
Kristen Brotzman, ELS高级监管服务经理
Dawn 已在 Certara 任职超过 13 年。她拥有监管写作和编辑经验，是一位经验丰富的提交负责人、公司培训师、技术编辑、项目负责人和作家。她带领着文件质量团队，其中包括我们的技术编辑和质量控制团队。
Kristen has been at Certara for over 8 years. She is an experienced technical editor with skills that include project management, style guide maintenance, template development, document management, publishing, redaction, and employee training in addition to document editing. She has been a certified Editor of Life Science (ELS) since December 2014.
Dawn 已在 Certara 任职超过 13 年。她拥有监管写作和编辑经验，是一位经验丰富的提交负责人、公司培训师、技术编辑、项目负责人和作家。她带领着文件质量团队，其中包括我们的技术编辑和质量控制团队。
Kristen has been at Certara for over 8 years. She is an experienced technical editor with skills that include project management, style guide maintenance, template development, document management, publishing, redaction, and employee training in addition to document editing. She has been a certified Editor of Life Science (ELS) since December 2014.
