Lifecycle management (LCM) refers to the process of managing a medicinal product from its initial development through its commercial life. The LCM process involves ensuring that the product remains safe, effective, and high-quality throughout its lifecycle, and includes activities such as post-approval changes submissions, regulatory compliance, and product optimization.
Templarpharma is a leading regulatory service provider with extensive expertise in LCM. Our team of experienced regulatory affairs professionals provides end-to-end support for managing a medicinal product’s lifecycle, from development to post-approval changes submissions and beyond. We collaborate closely with our clients to develop customized regulatory strategies that ensure regulatory compliance while maximizing operational efficiency and minimizing costs.
Our LCM services include regulatory compliance and gap analysis, post-approval changes submissions, CMC consulting, and more. We help manufacturers optimize their products and processes to maximize productivity while maintaining compliance with regulatory guidelines. Our expertise in LCM enables us to provide ongoing support to ensure that our clients’ medicinal products remain safe, effective, and high-quality throughout their lifecycle.
In summary, LCM is a critical process for managing medicinal products, and Templarpharma’s expertise in regulatory affairs and compliance ensures that manufacturers can successfully navigate the challenges of product lifecycle management while focusing on their core business objectives.
Templarpharma Expertise
Templarpharma has extensive expertise in Lifecycle Management (LCM) of medicinal products, enabling manufacturers to maximize the value of their products throughout their lifecycle. LCM encompasses various post-approval activities, including product and process improvements, optimization, and expansion to new markets. Our experienced team provides customized LCM strategies to meet specific business needs and regulatory requirements.
One of the critical aspects of LCM is post-approval changes management, which involves ensuring compliance with regulatory guidelines while making necessary changes to the product or process. Templarpharma offers end-to-end support for post-approval changes management, including evaluation of proposed changes, preparation of regulatory submissions, interaction with Health Authorities for approval, and implementation of the changes. Our team has extensive experience in handling various post-approval changes, including CMC variations, amendments, and supplements.
In addition to post-approval changes management, our LCM services include product optimization, such as process improvements and cost optimization. Our team works closely with manufacturers to identify areas for improvement and implement changes while ensuring compliance with regulatory guidelines.
Expansion to new markets is another aspect of LCM. Templarpharma provides support for the development of regulatory strategies to enter new markets, including preparation of regulatory submissions, interaction with Health Authorities, and compliance with country-specific requirements.
Our team also provides ongoing support for maintaining compliance with regulatory requirements, such as monitoring of pharmacovigilance and updating dossiers as necessary.
Overall, Templarpharma’s expertise in LCM enables manufacturers to maximize the value of their products throughout their lifecycle, ensuring compliance with regulatory guidelines and facilitating expansion into new markets while optimizing costs and maintaining high-quality standards.
CMC Annual Report Submissions in Lifecycle Management (LCM)
- 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 in Lifecycle Management (LCM)
- 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.