Workshops to get ready for Serialization

I am ready for a long road flight for work with a week- or months-long projects.

We help companies get ready for

Empower your team, ensure compliance, and lead with confidence in the world of serialization.

Led by seasoned professionals, Utrace has been at the forefront of over 50 implementation projects in prominent pharmaceutical and FMCG companies.

(01)

LET'S GO!

Online workshops

Home

Are you ready for serialization?

Global evolution

Сompliance with new regulatory requirements is a big challenge for pharmaceutical companies.

Beyond the European Union, Russia, UAE, Saudi Arabia, and the USA, over 30 countries have already embraced or are in the process of initiating serialization and traceability.

Pharma serialization
is not just a trend,
it is an evolving global standard.

LET'S GO!

When serialization requirements are introduced in a country, pharmaceutical companies face many challenges, for example:

Challenges

Understanding
New Regulations

Each country's serialization requirements can be intricate and unique. Grasping the specifics and nuances of these regulations can be daunting for pharmaceutical companies, especially if the legislation is dense or lacks clarity.

Adapting Existing
IT Systems

Incorporating serialization processes often necessitates significant modifications to existing IT systems or the adoption of entirely new systems. Ensuring these systems communicate effectively and maintain data integrity can be complex.

High
Implementation Costs

The initial investment required for serialization – including hardware, software, training, and potential line modifications – can be substantial, posing financial challenges especially for smaller companies.

Training and Skill Development

Existing staff may not be familiar with serialization processes, requiring comprehensive training programs to ensure that employees understand and can execute their roles efficiently.

High
Implementation Costs

Operational Disruptions

The incorporation of serialization processes can disrupt standard manufacturing and packaging operations. Production might slow down initially as serialization steps are integrated.

Data Management Challenges

Serialization generates a large volume of data that needs to be stored, managed, and possibly shared with regulators or partners. Handling this data securely and efficiently is crucial.

Supply Chain Modifications

Serialization can affect the entire supply chain, from manufacturing to distribution. Aligning all entities in the supply chain to ensure end-to-end traceability can be a significant undertaking. 

Lack of Internal Expertise

Companies might not have experts on staff familiar with serialization, leading to a reliance on external consultants or vendors, which can be costly and might not always align with the company's specific needs.

Ensuring Third-party Compliance

If a company uses third-party manufacturers, distributors, or partners, ensuring these entities also comply with serialization requirements becomes crucial, adding another layer of complexity. 

Continuous
Regulatory Monitoring

Regulations can evolve, requiring companies to stay updated on any changes to ensure ongoing compliance. 

Verification
and Validation

Once systems are in place, they need to be thoroughly tested and validated to ensure they work correctly and consistently, which can be a time-consuming process.

The Reason why they face these challenges

Lack of expertise in implementing
the serialization compliance projects

The change you need

Dive in from the start and understand
the basics of serialization to get ready:

What the project сonsists of

How to plan the project

How to choose a supplier

How to manage typical risks

How to assess readiness for launch

Who we are

Learn from experts – Utrace is a Pioneer in Serialization

Leading-edge serialization software solutions provider

Our mission

is to leverage track and trace technologies to help companies confidently navigate an ever-changing environment and gain benefits by increasing supply chain transparency, and consumer engagement in a sustainable way.

50+
Clients
100+
team members
100%
clients recommend us

In experts we trust

Arif Gadzhiev
Sustainability and Traceability Projects Director
Arjun Guhathakurta
Arjun Guhathakurta
Life Science Director – Operations
Convalgroup Company
Konstantin Ivanov
CEO Utrace Solutions