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GlobalSubmit™ REVIEW

迅速、シンプル、簡単なeCTDレビュー

デモのご相談

複雑な規制手続きのための eCTD 提出レビューを簡略化

GlobalSubmit REVIEW is a cutting-edge eCTD viewer designed to simplify and accelerate the regulatory submission review process. Regulatory professionals face immense challenges in ensuring timely and accurate eCTD submissions, often involving multiple stakeholders and complex approval workflows. GlobalSubmit REVIEW addresses these challenges by providing a streamlined, cloud-based platform that ensures compliance, reduces delays, and enhances collaboration. With its intuitive interface and robust capabilities, GlobalSubmit REVIEW empowers teams to confidently manage health authority-compliant eCTD submissions.

Streamline the eCTD review process, anytime and anywhere

GlobalSubmit REVIEW is purpose-built to meet the demands of a complex regulatory environment. By enabling seamless collaboration across stakeholders, this eCTD viewer ensures that your global submissions are reviewed efficiently and accurately. Whether managing investigational or marketing applications, GlobalSubmit REVIEW provides the tools needed to navigate the submission process with confidence.

  • Supports a wide range of submission types, including IND, NDA, sNDA, ANDA, BLA, MAA, DMF, ASMF, NDS and more
  • Fully compliant with 21 CFR Part 11 regulations
  • Seamless integration with leading electronic document management systems (eDMS)
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6
Number of global health authorities we support - FDA, EMA, Health Canada, Swissmedic, TGA (Australia), PMDA (Japan)
9
Submission types supported - IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS and more
200
Error conditions utilized, including 40+ PDF checks
50%
Faster to load submissions, reducing wait time

迅速、シンプル、簡単なeCTDレビュー

Streamlined review process

GlobalSubmit REVIEW simplifies the eCTD review process by providing a user-friendly interface and advanced tools that reduce the risk of errors and delays.

Cloud-based accessibility

Access your eCTD submissions anytime, anywhere with a secure, cloud-based platform, reducing IT overhead.

規制準拠

Ensure compliance with health authority standards, including 21 CFR Part 11, with every submission.

Travel a better road to submission

規制当局の要件に準拠したeCTD申請を迅速かつ正確に作成

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AI生成コンテンツにより規制文書作成を効率化し、ライターは重要な解析、メッセージ作成、レビューと改善に専念することが可能となります。

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Pinnacle 21 臨床データ管理と自動化一式を用いて、臨床試験の申請データのスピードと質を向上。

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なぜサターラが選ばれるのか

Certara leads the industry in regulatory science, providing cutting-edge tools and services that empower life sciences organizations to achieve their goals. GlobalSubmit eCTDソフトウェアを導入すると、申請プロセスの簡素化、加速、そして質の向上を実現する、最高水準のソリューションをご利用いただけます。

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1.5m
The number of regulatory submissions managed with GlobalSubmit
オンデマンド・ウェビナー
GlobalSubmit Review x あなたの専門知識：提出物のレビュープロセスを効率化するには

Have you ever wondered how you could speed up the submission review process without compromising quality? Join us to learn more about the time-saving features of GlobalSubmit Review, such as Crosscheck, live validation, and more. We will explore these features as well as discuss how they can add efficiencies to your submission process.

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GlobalSubmit 4.0 ウェビナー

eCTD（電子化コモン・テクニカル・ドキュメント）v4.0の導入により、電子規制申請の世界は大きく変わろうとしています。本規格の最新版には、電子規制文書の作成および提出に関する仕様とガイドラインの更新内容が盛り込まれています。
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Your data is safe with GlobalSubmit REVIEW

Certara’s eCTD software is ISO-certified, ensuring the highest standards of data security and compliance.

デモのご相談

Discover how GlobalSubmit REVIEW can streamline your eCTD submission review process.

Simplify collaboration across stakeholders
Ensure compliance with health authority standards
Reduce delays and enhance submission accuracy


FAQs

What types of submissions does GlobalSubmit REVIEW support?

GlobalSubmit REVIEW supports IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS, and more.

Is GlobalSubmit REVIEW compliant with 21 CFR Part 11?

Yes, GlobalSubmit REVIEW is fully compliant with 21 CFR Part 11 regulations.

Can GlobalSubmit REVIEW integrate with my existing eDMS?

Absolutely, GlobalSubmit REVIEW seamlessly integrates with leading electronic document management systems (eDMS).

Is GlobalSubmit REVIEW cloud-based?

Yes, GlobalSubmit REVIEW is web-hosted, so no installation is required, and it is compatible with all operating systems and browsers.

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