Getting a medical device or pharmaceutical company up and running in Germany and Europe might be difficult. Without expert knowledge of the system and the actions to take, navigating the process can be tough. Your company may start building effective operations in Germany and Europe with this list of 7 steps from Kalms Operations.
Step 1: Before visiting Europe, complete all essential pre-requisites.
There are various requirements you must meet before commencing the process of establishing your operational business in Germany. For any product you want to sell or distribute in Germany or Europe, you must first secure a CE mark. This phase is critical since, with a few exceptions, no product can be sold in the EU without a CE mark, except for research. In many situations, you’ll also need to register your business with the German Institute for Medical Documentation and Information, or DIMDI. Furthermore, any documentation pertaining to your operational business in Germany must be translated into German.
Meanwhile, setting up a shop in Germany can take a long time. You must take numerous procedures both within your organization and with German authorities. As a result, the relevant forms should be prepared ahead of time to guarantee that the procedure runs well. All other European countries have similar legislation, with some minor and major differences.
Kalms Operations has produced a thorough pre-requirement checklist of forms to complete to help healthcare logistics companies speed and simplify the process. This checklist can help you confirm that your organization and products are ready to start doing business in Germany and Europe. Kalms Operations is here to make sure the process goes as smoothly as possible.
Step 2: Verify that the warehouse you use satisfies all of your quality requirements.
In the healthcare industry, warehousing in Europe allows you to provide faster delivery times. Because shipments and customs processing may be handled locally, you can save time and money.
For small and mid-size businesses, opening an overseas branch can be too expensive; consequently, a third-party warehouse provider may be the answer. Warehousing requires not just providing storage in Europe, but also adhering to high quality requirements.
You’ll need a warehouse that adheres to Quality Management requirements to sell your medical equipment and pharmaceuticals in Europe. The warehouse should be ISO 13485:2016 accredited and capable of fulfilling all of your fulfillment requirements. Proper and secure storing methods, management of expiration dates, warehousing software with LOT-Management, international shipping of goods, invoicing of goods, and customs requirements and applications for shipments around the world are all important features to look for in a warehouse.
In addition to being ISO 13485:2016 compliant, the warehouse should follow your SOP (Standard Operating Procedure). This includes a warehouse that will promptly report any input, particularly client feedback. Furthermore, in the event of a product recall, your warehouse must assist you with communication and return shipment while closely adhering to your instructions and standard operating procedures.
Kalms Operations’ Berlin warehouse complies with all quality standards, and as a Third Party Logistics (3PL) supplier, we can dependably meet your needs, from a single cargo to frequent shipments. In terms of service, warehousing, risk analysis, product handling, and compliance/code of conduct, we adhere to your SOPs and quality requirements (regulatory).
Step 3: Find a third-party logistics partner who can meet your fulfillment demands with flexible services.
You’ll need a Third Party Logistics (3PL) partner with considerable healthcare logistics knowledge as your operating business in Europe grows. As you grow, your 3PL partner should help business become more competitive by tailoring their services to you. When selecting a fulfillment provider, look for a flexible fee structure and fulfillment costs that are based primarily on product shipping volume, as well as replenishment of consignment stock at clinical sites (if applicable), support with product recalls and customer mailings (marketing, customer information), invoicing, VAT handling, and bad debt collection. In addition, your fulfillment partner should be able to answer all of your inquiries about bookkeeping and tax declarations and, if necessary, supply these services.
Not only will Kalms Operations’ Third Party Logistics services be flexible and tailored to your needs, but we will also be actively involved in ensuring your success. Our services can be added or removed as needed, and they are tailored to your company’s needs and size in Europe. To increase communication and efficiency, we regularly monitor our services and procedures.
Step 4: Create a bilingual, local customer service team.
Customers in Europe desire local customer assistance that is available in their time zone and speaks their language. However, hiring a customer service crew in Europe is both expensive and time-consuming.
Customer service is responsible for not just taking orders, but also for effective complaint management and meeting the demands of your clients. A multilingual, locally based crew must handle all issues, offer delivery status, and manage payment options. They should also provide monthly statistics on the quantity of shipments, customers to whom shipments were made with shipping information, issued invoices, warehouse inventories, and the shelf lives of stored goods.
The purpose of Kalms Operations customer service is to provide these services in such a way that customers have a favorable experience. Dedicated phone numbers and fax lines will be used by our team to answer the phone in your name. We will deliver service at the times and locations agreed upon for your goods. They will also handle orders, provide services, respond to queries, use a customer-branded email address, store all customer-related documents and files, and provide monthly statistics.
Your company can establish a virtual office with your locally based customer care team to strengthen your presence in Germany. This is advantageous since it allows you to establish a presence in Germany without having to set up a formal business, which would entail renting an office and recruiting employees. You can start establishing yourself in Germany with a virtual office with Kalms Operations in Berlin.
Our multilingual customer care team will constantly go above and beyond for your company and your clients, from effective complaint management to product handling. Furthermore, creating a virtual office might help your company’s visibility and effectiveness in Germany.
Step 5: Logistics for marketing materials
When you start selling your medical gadget in Europe, finding a warehouse for it will be your top priority. However, locating a source for marketing material warehousing and logistics should be a top concern. This could even be used before to a commercial launch, such as when advertising a new product at a conference. Your company will have to ship material, and possibly heavy equipment, overseas to clients or venues as needed if it does not have a marketing material warehouse in Europe, which is both costly and time consuming.
You can save time and money by sending your marketing materials in bulk and enabling a warehouse to handle the logistics of shipping to clients by using a warehouse. Similarly, if your company participates in an international trade show or congress, the logistics of setting up and dismantling your stand are time-consuming and expensive. You can instead use a warehouse’s marketing material logistic services to organize the delivery and safe return of your booth supplies.
Kalms Operations can handle all of your marketing material logistical requirements. With our Central-European marketing warehouse, your customers and team will receive product information, traditional marketing materials, and product samples/equipment quickly, at a reasonable cost, and with a greatly decreased chance of damage. The assistance of Kalms Operations significantly minimizes the requirement for large shipments to Europe. We keep track of your marketing materials in stock, as well as shipments to events or clients, and we coordinate the delivery and safe return of all marketing materials and other booth items from conferences and trade shows.
Step 6: Improve your business development plan and increase sales.
Is your product achieving its objectives? It’s easy to lose track of your product’s success in the intricate structure of European healthcare systems. Small changes can sometimes make a tremendous difference, especially when using expert contacts in the health care field. While business development may not be at the forefront of your thinking when you expand your company in Europe, it is an important component that helps your firm establish long-term value.
Kalms Operations creates an entire strategy for reaching out to potential customers and converting them into customers of your product or service. We help you communicate the benefits of your products to your target clients based on their needs, competitive pressures, and communication methods.
We evaluate segmentation, ability to pay, market conditions, competitive actions, margins, and cost when developing your pricing plan. The strategy will be aimed towards a certain set of clients as well as competitors. We assess the impact of reaching your clients directly, online, over the phone, or through a combination of different channels; hiring a distributor or sales agent may also be a factor. We suggest a sales and distribution structure that will enable your company to successfully implement this approach.
Kalms Group provides you with custom-made solutions. Kalms Consulting, in addition to Kalms Operations, assists in market success by choosing the optimum approach to reimburse your goods.
Step 7: Find a logistics partner in your area (Kalms Operations)
It is not easy to achieve operational success in Germany and Europe. That’s why you’ll need a seasoned logistics partner you can rely on to help you navigate the process.
Kalms Operations is there for you from the beginning. When you first reach out to begin clinical trials, you may simply have a few shipments and only require assistance with a few other actions. We’ll be on hand to answer any questions you have about how a hospital can buy your gadget, the restrictions for giving out free samples of your product, how to invoice, VAT, and customs. Kalms Operations excels at explaining the steps involved in starting operations in Germany.
As a result, Kalms Operations is the best option; we provide practical logistics solutions to ensure your operational success in Germany and Europe. We provide core logistical and administrative services for firms who require a distribution center in another country as a Third Party Logistics provider.
Our goal is to be your smart one-stop shop for all of your logistics and storage needs, and we’ll play a key role in your success. This objective is aided by providing personalized and multilingual customer service, adaptable and scalable service modules, and same-day responses to your clients and concerns, all while adhering to all regulations.
Whether your European firm is just getting started or is already up and running, a trustworthy partner is critical to its success. We are the finest choice for expanding your business throughout Europe and establishing a profitable distribution network.