Publishing and Submissions Competencies

Overview

Freyr assists Life Sciences organizations to streamline the complete Regulatory submissions management process, right from dossier development, submission planning, tracking, publishing to final submissions to Health Authorities (HAs) including delivery confirmation/acknowledgement. As global HAs are accepting submissions in electronic format, the need of the hour is to deploy robust and ever-updated publishing and submission tools to manage region-wise submissions and region-specific formats.

Freyr ensures error-free Regulatory submissions with utmost quality and has been proven for on-time Regulatory publishing and submission services for all kinds of submission formats such as, paper, electronic, eCTD and NeeS.

Regulatory Submission Planning

Activities that establish the submission plan, identify submission components, roles and responsibilities and promote an understanding of associated processes e.g.: Submission Planning and Management Team (SPMT) activities that promote an emphasis on global participation to optimize harmonization of documents

Document Planning, Authoring, Review and Approval

Activities that define the format and content of submission documents and the processes associated with document authoring, review and approval that results in submission-ready components; e.g.: author/contributor seminars, document table of content, planning meetings, consensus meetings and automated authoring tools

Agency Review and Approval

Activities supporting the review and approval of the marketing application by Regulatory Agencies, e.g. submission of the final labeling, pre-approval inspections, responses to requests for information, mutual recognition procedure and centralized procedure response packages and preparation for meetings

Post-Approval Follow-Up

Continuous support for the product throughout its Lifecycle, i.e., post-approval commitments, annual reports, periodic safety update reports, variations and renewals

Regulatory Submission Assembly and Publishing

Includes processes that apply pagination, indexing and volumization in addition to the rendering of application components into electronic media and paper deliverables
Finishing activities include those activities associated with the creation of region/ country-specific application versions and may include creation of electronic submission, burning CDs and binding

Regulatory Submission Delivery

Delivery mechanisms to provide Regulatory submissions to local Regulatory subsidiaries, agencies worldwide and internal customers, e.g. delivery of the electronic submission, archiving submissions to the designated repository and shipping hard copy versions

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

Publishing and Submissions Competencies

Overview

Regulatory Submission Planning

Document Planning, Authoring, Review and Approval

Agency Review and Approval

Post-Approval Follow-Up

Regulatory Submission Assembly and Publishing

Regulatory Submission Delivery

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