GlobalSubmitCertara
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PharmaPendiumElsevier
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About
Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire document lifecycle and meeting your organization’s goals on expediting your release to market. With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients. As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions.
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About
PharmaPendium is a comprehensive resource that provides access to FDA and EMA drug approval documents, including pharmacokinetic, pharmacodynamic, and safety profiles. It offers detailed information on drug-drug interactions, adverse effects, and clinical study outcomes, facilitating informed decision-making in drug development and regulatory submissions. The platform's extensive data supports researchers and healthcare professionals in evaluating drug efficacy and safety, contributing to the advancement of pharmaceutical research and patient care. Find information about previous regulatory submissions and profit from precedents to predict agencies’ requirements. Seamlessly move from table view to interactive charts, graphs, and visual aids to easily interrogate and interpret data. Find information by adverse events (MedDRA), targets, indications, drug,s and endpoints using normalized data. Result pages bridge the preclinical to clinical divide.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Companies seeking a solution designed to simplify complex regulatory processes
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Audience
Pharmaceutical researchers and regulatory professionals interested in a tool to manage their drug approval data to inform development strategies and ensure compliance
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationCertara
Founded: 2008
United States
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/
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Company InformationElsevier
Founded: 1880
Netherlands
www.elsevier.com/products/pharmapendium
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Categories |
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Integrations
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Integrations
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