Pharma serialization consultancy
with added value

Excellis Europe consult with all companies within the pharmaceutical supply chain. We utilise our extensive knowledge of the vertical markets in the sector. It enables us to work effectively with leading fortune 200 companies.

We provide clarity and intelligence that leads to action. This is combined with our excellent client service, creativity and innovation to deliver a solution that works for you and the entire pharma supply chain.

Our services cover:

We consult on each service individually or combine them to deliver a full serialisation programme for you. Excellis Europe are the leading subject matter experts on pharma serialization regulations. Choose Excellis Europe and gain access to over 150 years’ industry experience.

Our methodology

Our methodology is based in real hands-on experience and serialization expertise. It has been honed, proven and always delivers success for our clients.

Excellis Europe maintain a customer-centric approach throughout our strategic consultancy. We pair this with an understanding of the current, past, and future outlook for the pharmaceutical industry. This understanding drives value beyond compliance in our serialization solutions and IT solutions.

From product security and brand protection to patient support to sales analysis, we understand how to adapt your existing systems to add this value for the future whilst also becoming compliant.

Program delivery

Program delivery must be thorough to achieve compliance and add value. Excellis Europe extensively plan the over-arching project which include all process flows and global architecture that will act as a control point throughout implementation.

This delivery method ensures a fully documented approach for you and your stakeholders. It also ensures all interdependent actions and projects are documented enabling unexpected challenges or delays to be fully shown and understood across all elements.

For Manufacturers:

  • Audit and Strategy
  • Program Design
  • URS
  • Vendor selection and management
  • Program management
  • SME
  • CMO integration program
  • Change management

For CMOs:

  • Audit and strategy
  • Client assessment
  • Architecture, integration with clients
  • Vendor selection and management
  • Program management
  • SME
  • ‘Frame’ solution offering
  • Change management

For EPCIS

  • Audit and strategy
  • Architecture
  • URS
  • Vendor selection and management
  • Master data management
  • Integration services
  • ‘Frame’ solution offering
  • Change management

For Supply Chain:

  • Awareness training
  • Strategy
  • Use cases
  • Integration processes – automation
  • ‘Frame’ solution offering
  • Change management

Computerised System Validation

Excellis Europe cover all key elements of a serialisation programme especially validation. A validation strategy and testing process is key to a traceability implementation that will ensure all packs can be tracked at every stage.

Our traceability matrix and system risk assessment ensure all scenarios are thought about and steps put in place to deal with any eventuality. Validation summary reports are embedded within the strategy to ensure satisfactory completion at every site.

Training

We offer training within your program delivery or independently. Whatever stage of your serialisation journey you are at, we can tailor world-class training to meet the needs of your program  and company. Excellis Europe are uniquely qualified to deliver comprehensive training that provides clear and relevant guidance.

Training is delivered through plenary and interactive workshops session internally or externally to suit you. Over the course of 1 to 2 days we will address the key aspects of a manufacturer’s readiness response including:

  • Analysis of key legislative requirements
  • Defining a strategic approach
  • The technology stack
  • Building user requirements
  • Vendor selection and management

We will also help you with your stakeholder engagement. Our unrivalled understanding of the serialisation and the pharma industry enables us to highlight where streamlining of processes, that may bring cost savings or increased sales, can be introduced as part of the meeting the EU-FMD requirements.

Rescue jobs

Excellis Europe can work with you at any stage of your serialization implementation programme.  We will also tailor our consultancy to suit your circumstances. This might be providing thought-leading advice to your in-house serialization delivery team or working within your teams to get you to compliance.

Implementing serialization is a challenge and not everyone gets it right first time. Traceability is rarely straight-forward, understanding its full scope is one thing but reacting to unforeseen issues such as project milestones slipping away is quite different.

We have the experience and expertise to not only develop the right solution from the start but to also implement the right solution midway through a project.