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Description

The transparency reporting obligations outlined in AIFMD Annex IV pose significant difficulties for Alternative Investment Fund Managers (AIFMs). Every authorized and registered AIFM must periodically submit reports to their respective local regulators regarding each Alternative Investment Fund (AIF) they manage or market within the European Union. Matterhorn has developed an innovative AIFMD Annex IV reporting software solution that is designed to be more efficient than competing options on the market, enabling substantial reductions in annual regulatory reporting expenses. This software requires minimal user input to generate both AIF and AIFM AIFMD Annex IV reports. Furthermore, once the initial reports are created, subsequent AIFMD Annex IV submissions can be completed in a fraction of the time, as the software effectively reuses existing data. The system produces XML AIFMD Annex IV output files that can be uploaded to all EU regulators with just a few clicks, streamlining the reporting process even further. Overall, this efficient solution not only simplifies compliance but also enhances the overall reporting experience for AIFMs.

Description

The K2C PSMF Solution represents an innovative methodology for overseeing the Pharmacovigilance System Master File. Periodic updates to this document are essential whenever there are noteworthy modifications in the pharmacovigilance procedures. Such modifications necessitate collaboration among various roles within the company to edit a document comprised of consistent paragraphs and annexes dictated by regulatory standards. However, coordinating edits can be challenging, especially since certain content must remain exclusive to specific editors and inaccessible to other contributors. The K2C solution addresses this complexity by treating individual paragraphs and annexes as separate documents, facilitating the creation of the final PSMF document through the merging of these various source materials. Additionally, the K2C PSMF Solution encompasses the management of contributions to the PSMF (including both paragraphs and annexes) as distinct entities, the regulation of access rights for both viewing and editing contributions, and comprehensive oversight of the entire document lifecycle, ensuring efficiency and compliance throughout the process. This streamlined approach enhances collaboration while maintaining regulatory adherence.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft SharePoint

Integrations

Microsoft SharePoint

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

€8,500 one-time payment
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Matterhorn Reporting Services

Founded

2014

Country

Netherlands

Website

www.matterhorn-rs.com

Vendor Details

Company Name

K2C

Country

United Kingdom

Website

www.k2c.com/products/K2Pharma/PSMF.html

Product Features

Product Features

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