FDA ESG Integration: Why Now Is the Time to Move Beyond Manual Submissions Blog FDA ESG Integration: Why Now Is the Time to Move Beyond Manual Submissions Discover how FDA Electronic Submissions Gateway (ESG) integration reduces manual work, improves compliance, and accelerates…Certara2026年4月20日
Ready for ESG NextGen, or still submitting like it’s 2015? オンデマンド・ウェビナー Ready for ESG NextGen, or still submitting like it’s 2015? Learn how to prepare for ESG NextGen with automated, compliant submission workflows. Watch the webinar…Certara2026年2月5日
Certara and ANVISA Partner to Launch eCTD 4.0 Submissions of Drug Applications in Brazil Through GlobalSubmit™ software Announcement CertaraとANVISAが提携、GlobalSubmit™ソフトウェアを通じてブラジルでの医薬品申請のeCTD4.0提出を開始 Certara and ANVISA have joined forces to enable eCTD 4.0 submissions in Brazil using GlobalSubmit™…Certara2025年11月13日
Differences between eCTD 4.0 and eCTD 3.2.2 Submissions – What You Need to Know On-Demand Webinar Differences between eCTD 4.0 and eCTD 3.2.2 Submissions – What You Need to Know Access our on-demand webinar to explore the key differences between eCTD 4.0 and eCTD 3.2.2.…Certara2025年8月11日
Regulatory Operations Best Practices for Health Canada Submissions Blog Regulatory Operations Best Practices for Health Canada Submissions Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and…Certara2025年8月11日
FDA ESG NextGen for Regulatory Submissions Blog FDA ESG NextGen for Regulatory Submissions The FDA ESG NextGen for Regulatory Submissions has replaced the FDA’s WebTrader and simplifies pharmaceutical…Certara2025年6月25日
eCTD 4.0: When & Where it will be Implemented Next On-Demand Webinar eCTD 4.0: When & Where it will be Implemented Next Associate Director, Regulatory Operations Over 20 years of experience in eCTD submissions and FDA interactions.…Certara2025年4月11日
GlobalSubmit eCTD 4.0 Webinars On-Demand Webinar GlobalSubmit eCTD 4.0 ウェビナー The world of electronic regulatory submissions is about to change with the introduction of eCTD…Certara2024年12月3日
Best Practices for a Successful eCTD Submission Blog eCTD申請を成功に導くベストプラクティス Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…Certara2024年3月5日
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Blog Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…Certara2023年12月12日