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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.

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.

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

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

Audience

Healthcare companies wanting a tool to streamline their collaboration and regulatory adherence

Audience

Chemical compliance

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

No images available

Pricing

€8,500 one-time payment
Free Version Not Supported
Free Trial Supported

Pricing

$100/month
Free Version Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Training

Documentation Not Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

K2C
United Kingdom
www.k2c.com/products/K2Pharma/PSMF.html

Company Information

RegAffairs AI
Portugal
regaffairsai.com

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Categories

Pharmacovigilance Supported

Categories

Integrations

Microsoft SharePoint Supported

Integrations

Microsoft SharePoint Not Supported
Claim K2C PSMF Solution and update features and information
Claim K2C PSMF Solution and update features and information
Claim RegAffairs AI and update features and information
Claim RegAffairs AI and update features and information