Artwork Competencies

Overview

Freyr is a leading provider of artwork services & solutions for the global life sciences industry - Pharmaceuticals, Medical Devices, Cosmetics, and Consumer Healthcare. Freyr provides Regulatory compliant, content integrated, intelligence-driven artwork solutions. As a one-stop-shop for artwork creation and artwork management, Freyr caters designs for wide-variety of product categories that include digital as well as print from packaging design to promotional designs.

Business Consulting

Centralization and Standardization of end-to-end Artwork Process
Packaging and Artwork Cost Reduction
Setting-up Strategies to Reduce Artwork Changes Globally

Tools Experience

Design2Launch Brand Manager, ePADEx, Oracle Agile (PLM)
DocuProof, DigitalPage, InForm/CC, Kodak Smart Review System (SRS)

Operational Support

Artwork Creation (graphic designing capability)
Proof Reading – Technical check, text and formatting
Graphic Coordination Technical Drawing/Die-line creation – CAD
Packaging and Printing Support
Process Documentation
System Implementation

Artwork Change Management

Product Branding (global)
Company Branding (global)
Market Authorization Holder Transfer
Manufacturing Site Transfer
Regulatory-Driven
Product Divestments
Third-Party Contract Manufacturer Integration

Tools And System Implementation

Electronic Proofreading
Labeling Document Management System
Automation of end-to-end Labeling Approval Process
UDI Implementation for Medical Devices

Validation And Testing

Validation and Testing
Unit Testing
Installation Qualification (IQ)
Operational Qualification (OQ)

What Our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is received! Thank you very much for your hard work, patience and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. Thank you again and look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company

Artwork Competencies

Overview

Business Consulting

Tools Experience

Operational Support

Artwork Change Management

Tools And System Implementation

Validation And Testing

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