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. However, many freight carriers only offer national cold-chain transport. Often, only passively cooled transport is available for international freight. Arvato provides an advantageous alternative. Using a direct connection, Harsewinkel feeds daily cold-chain shipments into the network of a local refrigerated carrier, where they are forwarded with active cooling. Delivery to Italy takes 48 to 72 hours (including delivery time) – approximately 24 hours longer than with passively cooled transport. On the other hand, there are savings of more than 20 percent due to lower cost of picking, optimised cardboard packaging and the elimination from the process of expensive insulated boxes. In addition to this, Arvato also guarantees GDP-compliant shipping.
The European transport market exhibits a wide range of variation in terms of delivery deadlines, reliability, cold-chain services and – of course – costs. Arvato’s artis in-house transportation system is a best-in-class solution that allows users to select the most suitable and most economical carrier for each consignment – whether it is a small package, an actively cooled transport, a courier or entire pallets. With more than 100 connected carriers, artis can be used to register and trace every consignment from a central point. Should something unexpected happen with a delivery, the system runs through known scenarios and suggests alternative ways to deliver the consignment on time. Another advantage is that no matter how many consignments customers dispatch or how many carriers they use, at the end of the billing period they will receive a sorted list of all their consignments, checked by Arvato.
The global healthcare market is changing. The issue drug safety is becoming an industrial and political priority – more and more states are working on legal regulations enforcing a precise identification of medication packaging. On a global scale multiple governmental initiatives are already present to fight drug falsification and submission of false claims.
Arvato Systems serialization experts are covering the whole process chain end-to-end within the healthcare segment with first-hand, already field-tested serialization solutions.
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 Healthcare has official authorisations from the EU for packaging, repackaging and labelling of medicines, and combines distribution and manufacturing at a single production site (Directive 2001/83/EC). Products are stored in a country-neutral condition, and just before shipment are provided with country-specific labels and package inserts by specially trained personnel in a strictly isolated, temperature and access-controlled area. Thanks to multi-user infrastructures, costs can be saved both for mass production and small batches.
Pharmaceutical companies profit from synchronisation of the postponement solutions with existing processes in the areas of logistics, sales, production and transport.
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.