Lifecycle Management (LCM)

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A Marketing Authorization Holder (MAH) is responsible for keeping the registered dossier up to date as per country-specific requirements for a products' lifecycle management. Based on the concerned Health Authority requirements, the MAH should file an Annual Report (AR) or a Renewal Request on a periodical basis. For  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, a 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 CMC lifecycle management Annual Report scheduler for due date.
  • Provide CMC lifecycle management Regulatory strategy and timelines for the 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 the Annual Report package.
  • Finalization of the Annual Report package and submission in the 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 the Health Authority/Country Manager before the renewal application due date.
  • Update the database with submission details.