Serialization Change Management

Mergers, carve-outs, product acquisitions, and divestments in the pharmaceutical industry often bring significant changes to established serialization landscapes. These strategic actions, while crucial for business growth and realignment, introduce technical and organizational complexities that must be meticulously managed to ensure continuity, compliance, and efficiency. The successful handling of these changes requires deep expertise in serialization systems, regulatory compliance, and change management. Vesdo is uniquely positioned to support pharmaceutical companies through these transitions. With extensive experience leading serialization change management projects, Vesdo has consistently delivered timely and effective solutions during mergers, acquisitions, divestments, and carve-outs. Our approach ensures that all aspects of your serialization system are seamlessly integrated or segregated, minimizing disruption and maintaining regulatory compliance. Serialization systems are integral to the pharmaceutical supply chain, ensuring product traceability, authenticity, and regulatory compliance. When a company undergoes significant changes, such as mergers or divestments, these systems must be adapted to reflect the new organizational structure. Vesdo’s Serialization Change Management services cover the full spectrum of activities required to manage these transitions, ensuring a smooth and efficient process.

The Vesdo Serialization Change Management covers the following:

Integration and Segregation of Serialization Systems and Infrastructure

In the case of mergers or acquisitions, integrating two distinct serialization systems into a cohesive whole is a complex task. Conversely, in divestments or carve-outs, segregating a serialization system to allow a smooth separation of entities poses its own challenges. Vesdo offers:

System Integration: Combining the serialization systems of merging entities, ensuring that all data, processes, and infrastructure are unified under a single operational framework. This includes the alignment of serialization standards, regulatory requirements, and system functionalities.
System Segregation: Separating serialization systems during divestments, ensuring that both the parent company and the divested entity retain compliant and functional serialization systems. This process involves careful planning and execution to avoid data loss and ensure continued regulatory adherence.

Workflow and Process Adjustments

Significant organizational changes necessitate adjustments to workflows and processes associated with serialization. Vesdo supports these adjustments by:

Process Mapping: Analyzing existing workflows and identifying the necessary changes to accommodate new organizational structures. This may involve redefining roles, adjusting serialization procedures, and optimizing workflows to ensure efficiency.
Change Implementation: Implementing the required process adjustments, ensuring that all stakeholders are trained and that the changes are integrated seamlessly into daily operations.
Continuous Improvement: Identifying opportunities for further optimization in the new serialization landscape, ensuring that processes remain efficient and compliant in the long term.

Remodeling of Data Exchange Interfaces

Serialization systems rely heavily on data exchange interfaces to communicate with external partners, regulatory authorities, and internal systems. During mergers, divestments, or acquisitions, these interfaces often need to be remodeled to accommodate new structures or segregated systems. Vesdo offers:

Interface Redesign: Reworking data exchange interfaces to align with the new organizational setup, ensuring that all parties can continue to exchange serialization data accurately and securely.
Testing and Validation: Conducting thorough testing of redesigned interfaces to ensure they function correctly and comply with regulatory requirements. This includes end-to-end testing to verify data integrity across the entire supply chain.
Stakeholder Coordination: Working closely with business partners, regulatory authorities, and internal teams to ensure a smooth transition with minimal disruption to data exchange processes.

Data Migration

Data migration is a critical component of serialization change management. Whether you’re integrating systems following a merger or transferring data during a divestment, Vesdo ensures that your serialization data is migrated accurately and securely. Our data migration services include:

Data Mapping: Identifying the data that needs to be migrated, mapping it to the new system, and ensuring that all relevant information is retained.
Data Cleansing: Cleaning the data to remove any inconsistencies or inaccuracies before migration, ensuring that the new system operates with accurate and reliable information.
Data Transfer: Executing the data migration process, ensuring that all serialization data is transferred securely and accurately, with minimal downtime.
Post-Migration Validation: Verifying that the migrated data is correct and fully functional within the new system, ensuring that all serialization processes can continue without interruption.

Marketing Authorization Holder (MAH) Change-Over

A change in the Marketing Authorization Holder (MAH) during a merger, acquisition, or divestment adds another layer of complexity to serialization change management. This change must be managed carefully to ensure that the transition is compliant with regulatory requirements and does not disrupt product availability. Vesdo offers:

Regulatory Coordination: Managing the regulatory aspects of the MAH change-over, ensuring that all required notifications and approvals are obtained in a timely manner.
System Updates: Updating serialization systems to reflect the new MAH, ensuring that all serialization data is correctly attributed to the new entity.
Stakeholder Communication: Coordinating with all relevant stakeholders, including regulatory authorities, business partners, and internal teams, to ensure a smooth and compliant transition.

Why Choose Vesdo for Serialization Change Management?

Vesdo’s deep knowledge of serialization systems, combined with extensive experience in managing complex change scenarios, makes us the ideal partner for pharmaceutical companies undergoing mergers, acquisitions, divestments, or carve-outs. Our comprehensive services cover every aspect of serialization change management, from system integration and data migration to workflow adjustments and MAH change-overs.

By partnering with Vesdo, you gain access to a team of experts dedicated to ensuring that your serialization landscape is adapted smoothly and efficiently, minimizing risks and maintaining compliance throughout the transition. With Vesdo’s support, you can confidently navigate the complexities of serialization change management, ensuring that your operations remain robust, compliant, and effective.