Lifecycle Management - Overview
A Marketing Authorization Holder (MAH) is responsible for keeping the registered dossier up to date as per country-specific requirements for pharmaceutical product lifecycle management. Based on the concerned Health Authority requirements, the MAH should file an Annual Report (AR) or a Renewal Request on a periodic basis. Global Health Authorities have different requirements for filing annual reports or renewal submissions. In such scenarios, to get approval/acceptance at the earliest, a Regulatory submission strategy plays a significant role. Hence, manufacturers may consider 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) and pharmaceutical product lifecycle management for Regulatory submissions, offers CMC Regulatory affairs consulting to global pharmaceutical companies.
Lifecycle Management
CMC Annual Report Submissions:
- CMC lifecycle management by creating an Annual Report scheduler.
- Provide CMC lifecycle management Regulatory strategy and timelines for the required documents.
- Request 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 the renewal application scheduler.
- Provide CMC Regulatory strategy for documents required and timelines.
- Sending the renewal initiation documents request to the manufacturer and requesting 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.
- Expertise in Product Lifecycle Management (PLM) based on global Health Authority requirements.
- Regulatory support in managing drug development lifecycle.
- Specialized Chemistry Manufacturing and Controls consulting.
- Designing tailormade Regulatory CMC strategies.
