Life Cycle Management
MAVEN has an established Center of Excellence for Regulatory life cycle management and Post Approval activities
Post-Approval Changes
After receiving the approval or during commercialization of the product, if manufacturers realize and propose any changes (administrative/quality) to the registered content (that is dossier), those shall be informed to concerned Authority by filing supplements or variations or amendments, which are referred as post-approval changes.
Life Cycle Management
Apart from post-approval changes, marketing authorization holder is responsible for keeping the dossier updated periodically as per regional requirements for different industries products’ life cycle management.
Either post-approval changes, or annual reports or renewals, HAs worldwide have different set of requirements for filing the submissions. In such scenarios, to get the approval/acceptance at the earliest, Regulatory strategy plays a significant role.
Assistance in drug renewals or filling a variations (Type 1A, Type 1B and Type II) and also addresses Response to Queries with health authorities on timely manner and doing it in ‘First time Right’
We have expertise in following post approval services
- Change in manufacturing site, addition/deletion
- Marketing Authorization Holder (MAH) transfers
- Optimization of manufacturing process
- Change in formulation
- Batch size change
- Addition of new supplier for active substance
- Inclusion of additional source for starting material for drug substance
- Change in route of synthesis
- Certification of Suitability (CEP) updates/new CEP
- Change in equipment/instruments
- Analytical method changes
- Changes in container closure system
- Change in primary packaging material supplier
- Shelf life extension/reduction
- eCTD/CTD dossier preparation
- Drug license renewal applications
- Re-registration dossiers
Lifecycle Management/Post Approval Activities
MAVEN has an established Center of Excellence for Regulatory life cycle management and Post Approval activities
Post-Approval Changes
After receiving the approval or during commercialization of the product, if manufacturers realize and propose any changes (administrative/quality) to the registered content (that is dossier), those shall be informed to concerned Authority by filing supplements or variations or amendments, which are referred as post-approval changes.
Life Cycle Management
Apart from post-approval changes, marketing authorization holder is responsible for keeping the dossier updated periodically as per regional requirements for different industries products’ life cycle management. Either post-approval changes, or annual reports or renewals, HAs worldwide have different set of requirements for filing the submissions. In such scenarios, to get the approval/acceptance at the earliest, Regulatory strategy plays a significant role.
