Ensuring Documents of the Highest Quality

The types of regulatory documents required for a marketing application are numerous and complex. Because these documents represent many different disciplines and years of research and data critical for drug development, regulatory reviewers require documents to be written with specific content and in specific formats. Manual document management processes and disparate systems cultivate vast inefficiencies as sponsors struggle with:

  • 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.

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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.

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GlobalSubmit:eCTD Authoring Template Suite

We’ve paired our technical experts with our regulatory writers and editors to create a comprehensive eCTD authoring template suite. Our templates come pre-loaded with:

  • 専用のツールバー
  • 適切な文書フォーマット
  • 適切な文書粒度
  • 隠しテキストとして規制当局のガイダンスやベストプラクティス、エキスパートからの助言を表示
  • お客様を承認申請の成功へと導くベストプラクティスを実装

Our lead technical editors are experts on how to use and troubleshoot our template suite and are versatile enough to support other template suites.

Our authoring templates are the only templates built by regulatory writers for regulatory writers based on decades of experience planning, writing, and editing hundreds of global submissions.

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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.

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当社のチーム
Dawn Guyer Director of Document Quality, Synchrogenix

サターラにて 13 年にわたってメディカルライターとして活躍しています。レギュラトリーライティングと文書校正の両方の業務を経験し、経験豊富なチームリーダー、社内トレーナー、テクニカルエディター、プロジェクトリーダー、さらにライターとしての顔を持っています。現在、当社の Techincal Editing および QC チームも含む Document Quality チームを統括しています。

Kristen Brotzman, ELS Senior Regulatory Services Manager

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.

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