##  [Lifecycle Management](/index%2ephp/medicinal-products/lifecycle-management) 

# Lifecycle Management











- [Overview](#overview)
- [Expertise & Advantages](#expertise)
- [Testimonials](#testimonial)
- [Insights](#insights)







## 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



- [Expertise](#mdv-1)
- [Advantages](#mdv-2)

### 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.



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- 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.



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#### Streamline Your Pharmaceutical Product Lifecycle Management

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