Post Approval LCM
LCM is abbreviated as Life Cycle Management. LCM is a systematic approach to manage the chain of changes a product undergoes through, from designing and development to retirement. This part of the drug life cycle is as important as bringing in new medicines asthe patients are given continuously enhanced medicines. Tammina Life Science works on Operational Outsourcing of life cycle activities, offering services ranging from strategy consulting for Legacy Product Cycle Management (LCM) delivery models, and life cycle dossier management. Post-approval changes are introduced worldwide for the following –
- Upgrade to state-of-the-art facilities.
- Response to changes in regulatory requirements.
- Improve quality control techniques.
- Enhance the robustness and efficiency of the manufacturing process.
- React to increasing supply demand.
Post Approval Changes :
For pharmaceutical industry life cycle management, Post approval changes are an integral part. These changes need to be carefully checked and should follow the proper regulatory path of given jurisdiction.During commercialization or after receiving the approval of the drug product, if there are any changes which are realized by manufacturers and if they expect any changes to the registered content, that must be informed t the Health Authorities by filing amendments, variations or supplements. This is known as post-approval changes. These changes are categorized as –
- Minor changes – This do not require any prior approval from the Health Authorities for the implementation. This should be filed in Annual Report/Type IA/Type A.
- Moderate Changes – This requires approval from the Health Authorities prior to distribution of the drug made using the change. This should be filed as Changes Being Effected/Type IB? Type IAIN/ Type B.
- Major Changes – This requires approval from the Health Authorities prior to distribution of the drug product made using the changes. This should be filed as Prior Approval Supplement/ Type II/ Type C.
Tammina Life Science Regulatory Strategies for Post Approval Changes :
- Proposed changes are evaluated.
- Regulatory assessment of supporting documents.
- For filing the changes, the Regulatory approach is prepared.
- For submission/approval and implementation timeline, guidance is given to manufacturers.
- Compilation and submission of post approval changes submission.
- For review, follow-up with Health Authorities.
Why Tammina Life Science :
- Tammina Life Science works with Therapeutic Good Administration (TGA, Australia), Gulf Cooperation Council (GCC), Medicines Control Council (MCC, South Africa), USA, and the European Union for post approval changes.
- Our regulatory life science professionals are experts to handle pre-submission administrative activities.
- Our team has experts and great experience in compilation and submission and provides end-to-end regulatory support for development, registration and approvals of drugs and other products.
- We do changes in analytical methods, formulation, container closure system, and route of synthesis.
- We do Marketing Authorization Holder (MAH) transfers.
- We do changes in primary packaging material supplier.
- Pharma variation Filings are done by us.
- We track due-date for renewal application and annual report filing for Abbreviated New Drug Submission(ANDS), New Drug Submission(NDS), Abbreviated New Drug Application (ANDA), New Drug Application (NDA), and Investigational New Drug (IND).
- We request for additional documents for renewal application and annual reports.
- We provide Certification of Suitability (CEP) updates.