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 product’s 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, the 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 Lifecycle management and CMC Regulatory affairs.

Freyr Expertise and Advantages

Freyr Expertise

CMC Annual Report Submissions:

  • Tracking of Annual Report scheduler for due date
  • Provide CMC Regulatory affairs 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