Lifecycle Management (LCM)

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Overview

Overview

A Marketing Authorization Holder (MAA) is responsible for keeping the registered dossier up to date as per country - specific requirements for a products' lifecycle management. Based on the concerning health authority requirements, the MAA holder should file an Annual Report (AR) or Renewal request on a periodical basis. Either annual reports or renewals, Health Authorities worldwide have a different set of requirements for filing the submissions. In such scenarios, to get the approval/acceptance at the earliest, the Regulatory submission strategy plays a significant role. Hence, manufacturers may wish to consider a specialized Regulatory consulting for CMC Lifecycle Management of the Regulatory Submissions for already approved products.

Freyr, a leading player in centralized Chemistry, Manufacturing and Controls (CMC) lifecycle management for Regulatory submissions, offers services for CMC Regulatory affairs.

Freyr Expertise and Advantages

Freyr Expertise

CMC Annual Report Submissions:

  • Tracking of Annual Report scheduler for due date
  • Provide CMC Regulatory strategy and timelines for required documents
  • Request for a list of changes implemented in the reporting period along with CMC documentation
  • Regulatory assessment of the supporting documents
  • Request for additional documents/justification
  • Authoring of Annual Report package
  • Finalization of Annual Report package and submission in eCTD format
  • Updating the database with submission details and status

Renewal Applications:

  • Tracking of renewal application scheduler
  • Provide CMC Regulatory Strategy for documents required and timelines
  • Send the renewal initiation documents request to the manufacturer and request for CMC documentation
  • Regulatory assessment of the supporting documents for renewal application submission
  • Request for additional documents/justification
  • Authoring of renewal package in line with country - specific requirements
  • Finalization of renewal dossier and submission to health authority/country manager before renewal application due date
  • Update the database with submission details