Regulatory Labeling 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

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

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 

Latest Resources

  • Blogs

    ANVISA Becomes a Member of PIC/s Committee

    ANVISA Becomes a Member of PIC/s Committee

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  • White Papers

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

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  • Webinars

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner?

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