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 Labeling Competencies - Expertise
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
