Bridge to Europe
Entering the European market with Arvato
Step into the European market with Arvato. Our healthcare expertise supports European and non-European firms, from the final phases of clinical studies to establishing the product on the market. Bridge to Europe is ideal for start-ups. You have the innovative product, we have the local infrastructure and know the market.
From dedicated Healthcare facilities, we manage all order-to-cash processes from the time the order is accepted until invoicing, provide multilingual service for your customers, are familiar with the countless different legal formalities and customs requirements, and use integrated postponement solutions to give you the flexibility you need for the European market. Named Patient Supply services also facilitate delivery to selected patients before product authorisation has been granted. All processes and structures are certified in accordance with GMP and ISO.
My team and I have come to know arvato Healthcare as a company with committed employees, who have sound industry and process know-how and give us proactive support. When launching the first product in Europe, the adaptable process and flexible infrastructure available to arvato Healthcare have provided us with a supply chain solution which is custom-tailored to our needs.Anthony Flammia, VP Global Manufacturing & Supply at The Medicines Company
Named Patient Supply
Delivery of medicines even before the actual market authorisation is no problem at all with named patient supply service. Together with an experienced specialist, Arvato fulfils the legal requirements and facilitates strictly regulated delivery to patients who have already exhausted other treatment options. Arvato provides consolidated management of all processes, and ensures uniform adherence to the highest quality standards. Arvato also performs the mandated checking of addressees and resolves all customs issues. These services are available for both ambient products and refrigerated products. The requirements for storage and handling of narcotics are also observed.
Arvato supports pharmaceutical companies even before product launch, while Investigational Medicinal Products (IMPs) are passing through the final phases of the clinical studies – from the submission of the clinical trial application to competent authorities to the provision of scientific advice and the development of Certified Medical Education (CME). Naturally, Arvato also handles shipping in Phase IV and provides supplementary concepts for marketing your products. Trained personnel in the Arvato Service Centre also assist with patient recruiting and patient service.
Cold chain transport
Temperature-managed transport is essential for many medicines and medicinal products. In the meantime, there are a number of suitably specialized carriers in Europe, which are already in use for Arvato today. Since there is no Pan-European, cross-border network for actively cooled transportation, the only solution is to use insulated boxes or the use of non-tempered vehicles.
Arvato provides an advantageous alternative: Using a direct connection, the Harsewinkel headquarters feeds daily cold-chain shipments into the network of a local refrigerated carrier, where they are forwarded with active cooling. This so-called "local injection" allows us to offer actively cooled logistics across national boundaries. In addition, there are savings of more than 20 percent compared to the use of insulated boxes.
The European transport market exhibits a wide range of variation in terms of delivery deadlines, reliability, cold-chain services and – of course – costs. With access to more than 100 associated carriers, our carrier-independent transport management system (TMS) offers you flexible international transport options, by road, track, air and sea. At the same time, you will be benefiting from the buying power of a large logistics company.
Our TMS allows us to find the most suitable and cost-efficient carrier for any shipment, any time. Be it a package, transport for actively cooled goods, courier delivery or a whole range of products – leave the control tower function to us. Our TMS gives you an overview of all your goods’ movements at a glance. We will only provide you with one monthly consolidated invoice covering all transport. This reduces transport and administration costs.
With its proactive troubleshooting function, our flexible transport management also gives you the flexibility to react in the best possible way to unforeseen situations and to facilitate a timely delivery. We build on the ‘best-in-class’ principle to organise a heterogeneous European transport environment for our clients.
Seamless track & trace processes ensure that everything is adequately controlled and reported throughout the whole shipping cycle. This allows us to pinpoint individual shipments at any given time on demand, or to determine whether a product has been or will be delivered to the consignee within the specified deadline – in a carrier-independent and cross-border manner.
Implementing the Falsified Medicines Directive
To prevent falsified medicine from reaching pharmacies, serialization will be made mandatory in the EU by 2019. Only intelligent and high-performance IT systems are able to produce millions of serial numbers and apply them to the packaging for medical products. With the creation of its own Corporate Serialization Database (CSDB), which manages serial numbers and transmits them to contract manufacturers or packaging services as required, Arvato has developed a model that aims to prevent falsified medicines as best as possible.
A database is the optimal IT solution for your serialization management. A site module applies codes onto the folding boxes and communicates used serial numbers to national verification systems (e.g. in Germany, this would be ‘’Securpharm’). This allows pharmacies to determine whether medicines are real and verified and thus can be sold or not. Many other national verification systems in Europe already rely on Arvato’s IT expertise.
Arvato Systems serialization experts are covering the whole process chain end-to-end within the healthcare segment.
Cold chain management
Arvato offers the ideal logistics infrastructure for temperature-managed warehousing and transport of sensitive products. Depending on your needs, we can store products at -70°C, -20°C, 15–25°C or 2–8°C. A range of ingenious monitoring systems ensures that everything is constantly kept under exactly the right conditions.
Healthcare Risk Management
We also provide smoothly integrated solutions for products that are subject to the risk management process due to regulatory requirements regarding prescription and delivery. We manage all processes and bring them into line with the respective national guidelines. In addition to complete traceability along the entire distribution channel, we also need to ensure that products are only sent out to previously registered persons, for example, as only specially trained medical practitioners and staff members are permitted to prescribe or administer this medication. Queries stored in the system facilitate the exclusion of patient groups for whom the risk of side effects is too great. All the data required for the comparison is stored in databases at both the customer’s and Arvato’s premises. Hospitals provide the patient data in anonymised form to ensure optimum compliance with data protection regulations.
Time is of the essence in medical emergencies. Accordingly, Arvato offers its customers emergency deliveries anywhere in the world. An emergency number is available around the clock for deliveries that cannot wait. Specially trained Arvato personnel process the orders and ship the medicine. Of course, temperature management is used for those deliveries that require it, and the strict quality standards for pharmaceutical products and medical technology are observed. Arvato ships via a proven network of couriers, who convey the shipment as quickly as possible to where it’s needed.
Passively cooled delivery
Not all delivery routes have a network of refrigerated carriers. As an alternative, Arvato offers its customers passively cooled transport in insulated boxes. The boxes have been specially developed and validated for refrigerated transport. Packing processes adapted to the season ensure that, regardless of the outdoor temperature, the products are transported within the specified temperature ranges and retain this temperature for up to 72 hours. As a result, deliveries around the world arrive on time. Upon request, Arvato will also integrate the customer’s customised boxes into the distribution processes. For air freight shipments, there is also the option of using special Envirotainer transport containers.
Arvato’s central warehouse offers the necessary flexibility for reduced stock under the official licence related to packing, repacking, and labelling medicinal products (guidelines 2001/83/EC). Products are stored in a country-neutral condition, and just before shipment are provided with country-specific labels (e.g. Bollini) and package inserts by specially trained personnel in a strictly isolated, temperature and access-controlled area.
Pharmaceutical companies benefit from the synchronisation of the postponement solutions with existing processes in the areas of logistics, sales, production or transport. Arvato´s serialization solutions are also available under the Falisified Medicines Directive.
Of course we also help medical technology manufacturers to increase the flexibility of their stock, reduce costs, and react more quickly to demands made by the market or their clients. This includes, for example, intelligent kitting or print-on-demand solutions for information accompanying each product such as instruction manuals.
Direct to Pharmacy
Secure supply chains are now more important than ever. These days, counterfeit drugs can even find their way into pharmacies via traditional routes of delivery. With our direct-to-pharmacy model, we transact all order-to-cash processes – from order acceptance and logistics – including postponement processes – to invoicing and reporting. Healthcare companies thus receive integrated services from a single source. Pharmacies and patients alike profit from the security of obtaining products with reliable quality through a pre-determined, fully qualified and documented sales channel.