Related Products
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About
K2C PSMF Solution is a modern approach to the management of the Pharmacovigilance System Master File. This document typically requires periodic updates as per significant changes in the pharmacovigilance process. These changes require that multiple company roles are involved in editing a document that is composed of paragraphs and annexes that are all the time same because fixed by regulations. However co-editing is complex; in addition, part of the content should be reserved to some editors and even not available to other contributors. K2C solution allows handling the distinct paragraphs and annexes as single documents, then it offers the possibility to create the PSMF document as a merge of various source documents. K2C PSMF Solution includes management of PSMF contributions (paragraphs and annexes) as distinct documents; management of access rights for viewing or editing of PSMF contributions; and management of the entire lifecycle.
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About
RegAffairs AI is an AI research assistant for regulatory affairs, compliance and product stewardship teams. You ask a regulatory question in plain language and an agent researches it across 1,046 official regulation databases from more than 340 regulators in 43 jurisdictions, covering chemicals, pharma, food, cosmetics, pesticides, biocides, fashion and EHS. The answer comes back in minutes with every claim cited to the exact regulation, annex entry or judgment paragraph, and each citation opens the stored source document. The research trail, every search and document the agent read, is shown on the page, so the work can be checked and handed to legal. Answers come only from the indexed official text; where the record is silent, the answer says so. Typical questions: is a substance still listed or restricted, what changed after the last amendment, how two markets differ, and who has to notify by when. Questions are never used for training.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Healthcare companies wanting a tool to streamline their collaboration and regulatory adherence
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Audience
Chemical compliance
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and VideosNo images available
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Pricing
€8,500 one-time payment
Free Version
Not Supported
Free Trial
Supported
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Pricing
$100/month
Free Version
Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Company InformationK2C
United Kingdom
www.k2c.com/products/K2Pharma/PSMF.html
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Company InformationRegAffairs AI
Portugal
regaffairsai.com
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Categories |
Categories |
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Integrations
Microsoft SharePoint
Not Supported
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