Services.
When outsourced services are utilized for complex packaging solutions, swift action is essential. We strive to deliver significant added value to all stakeholders because we are absolutely convinced of the benefits of this system solution for our customers. Our motto is to embrace new technologies and pursue innovation leadership in the packaging of pharmaceutical products. Nature serves as a symbol for intelligent packaging and the outstanding development work of our project management.
Fast and flexible thanks to clear and simple structures
Both locations have experienced project managers in the areas of samples, technical projects and market launches. Each project is assigned a dedicated project manager as the main point of contact and each project team is complemented by a quality expert who monitors the regulatory requirements throughout the process. Lean and efficient organisation is a core element.
- Project management/single point of contact
- Clarifying all detailed specifications of a customer requirement and defining the central project objectives
- Checking whether all regulatory aspects have been considered
- Developing a schedule for all project-related activities
- Implementing the agreed procedures for communication and reporting with both the customer and partners (if required)
- Coordinating all project-related activities, providing guidance and direction where necessary
- Monitoring the progress of ongoing processes and reviewing the results
- Periodic reporting
Regulatory support
Packaging concepts and process development
Technical support (incl. machine procurement)
The whole achieves more than the sum of its parts
The Ivers-Lee Group considers one of its core competencies to be providing support for challenges in the supply chain of clinical samples and commercial products. One major asset of the Ivers-Lee Group is its EU location, where EU market approvals can be completed. The warehouse is located in Rheinfelden, Germany, where the following storage conditions can be met: 15–25 °C, 2–8 °C, -20 °C. The Ivers-Lee Group’s serialisation and aggregation system meets the requirements of all major markets.
- Procurement of comparator medication, storage and returns management (EU distribution)
Pharmaceutical warehouses (approx. 2145 pallet spaces), cold rooms (555 m2) and conditioning and ventilation facilities, monitored by data loggers, are part of the standard equipment for pharmaceutical production. We offer you customised concepts for your products that cover all your needs.
- EU import
In the run-up to an EU import, we check all the necessary and legal framework conditions for importing goods from third/MRA countries into the European Union. We undertake the necessary review and qualification of the supply chain and offer you the corresponding auditing.
- EU market approval/QP services (incl. vaccines)
With our key pharmaceutical personnel and qualified person(s), we handle all processes to get the finished medicinal products into circulation and trade in the EU.
We check your study medication for compliance with the authorisation of the health authorities and the ethics committee and release it for patient testing. Our employees’ many years of experience in this task make us the ideal partner for your consultation and quality assessment. Benefit from our audits and our quality management in the supply chain. Serialisation and aggregation
- Cold chain products
Cold chain products are very demanding. The processing time outside the cold chain must be documented in a complete and traceable manner, as maintaining the cold chain is a crucial quality feature of cold chain products.
The production site in Burgdorf has seven independent cold storage rooms with their own refrigeration units. The rooms are continuously monitored and appropriate alarms are provided. - Repackaging and relabelling activities
Packaging, repackaging and group packaging work can often only be completed with the help of semi-manual auxiliary equipment. In many cases, these jobs are under time pressure and must be completed quickly, without long lead times and still in compliance with regulations.
High-quality content requires appropriate handling
The Ivers-Lee Group has over 30 years of experience in packaging clinical samples. Thanks to a good network of partners, the Ivers-Lee Group can fulfil a wide range of customer requirements. Long-standing customers include non-profit organisations, start-ups and larger pharmaceutical companies. The range of services is rounded off with blinded products and suitable placebos. The Group can also print study labels, including randomisations. Labelling, packaging and assembling kits for clinical trials is our daily work. As part of the risk management of clinical trials, we also produce emergency envelopes (code-breaking documents).
- Blinding and matching placebos
We develop concepts for blinding your investigational medicinal products and procure matching placebo drugs.
- Label design and printing (incl. randomisation)
We design EU-compliant label texts and print them for you. For multi-layer labels/booklet labels, we work together with well-known service providers in the printing industry.
- Labelling, packaging and assembling kits for clinical trials
We package and label the investigational medicinal product created together with you at our Swiss site and handle approval and dispatch within Switzerland as well as export and approval to overseas and Europe. We are happy to perform the depot function for you.
- Analytics
We support you in the management of laboratory analytics. We are happy to search for suitable laboratories for you and qualify and audit them in accordance with EU regulations. Benefit from our experience! We are glad to handle the primary and secondary filling of stability samples and organise the shipment of samples to the stability testing site/laboratory.
Packaging provides protection and always aims to produce a clear benefit
Packaging thrives on innovation! Innovative packaging services are the key to success in the market. Acceptance by patients, user-friendliness and packaging security play a crucial role in this respect. Ivers-Lee aims to be recognised for its clear commitment to progressive solutions and its willingness to invest in this area today and in the future. Ivers-Lee works exclusively on systems from leading European manufacturers. In recent years, the final assembly of injection systems has become a core competence of the Ivers-Lee Group. The Group can look back proudly on more than ten years of experience in this field.
Device assembly
Blister packs
Bottling (solids)
Stick packs
- Secondary packaging (automatic/manual)
Our secondary packaging expertise is based on side-loading or top-loading technology and is supplemented by manual packaging.