Gate to Europe
Expanding Business Into The EU?
Just sit back and relax, we’ll handle everything for you!
HOW TO GET STARTED
Delivering Medicine To The European Union
There are a few key logistical tasks you’ll need to take care of in order to ensure a successful market entry. From navigating complex regulatory requirements to establishing a reliable supply chain and distribution network, our team has the expertise and experience to help you manage all aspects of your EU expansion.
Getting MAH rights
Complete Pharmaceutical Logistics Service Portfolio
We offer a complete pharmaceutical logistics service to get your products safely and efficiently into the EU market. Wherever you are in the process, whatever service you need, we can help you!
We assist with obtaining MAH rights and handling all administrative procedures.
– Business Development
– PV Services
– Drug Regulatory Affairs
– Pricing and Reimbursement
– Readability Testing
– Medical writing/Dossier development + eCTD
– Translation Services
We ensure that your business meets all regulatory requirements and you able to maintain the highest level of quality in your operations.
– Development, implementation and continuous maintenance of Quality Assurance Systems
– Responsible and Qualified person services
– Set up of technical agreements, site master files, quality manuals and policies
– Review study and batch specific documentation to the provisions of the MA
– Facility preparation and SOP development, team training, design of self inspection programs
We offer special pharmaceutical forwarding solutions and custom clearance service in compliance with all pharma and GDP requirements.
– „Temperature Controlled Products” Transportation Service
– Customs clearance and bonded warehousing services
– VAT Exempt Import Solutions
– AEO C Certificate
Our offer both manual and automated packaging solutions for a wide range of products including tablets, ampoules, and bottles.
Our packaging options include boxes, trays, and pallets to meet your unique needs. Our service also includes pharmaceutical serialization (mandatory in the EU!) and tamper-evident packaging to ensure the security and integrity of your products.
Our Cloud-based IT solution for drug serialization designed specifically for small and medium-sized enterprises to comply with the EU’s pharmaceutical serialization requirements.
– Low entry cost
– Rapid implementation (1-3 months)
– Seamless integration with other softwares (Tracelink, Antares, Systech)
– Fully validated system
– Online support
We offer tailor-made supply chain solutions in our fully licensed and validated warehouse, located in Budapest.
– Fully licensed and validated warehouse, maintaining cGMP/cGDP standards
– In-house developed and validated WMS System
– Data interchange for ordering, reporting and stock management by offering a maximum integration with partners’ IT system
– 24/7 manned security service, electric access control system and CCTV surveillance system
– Excellent geographical site location / 2 minutes from the motorways, 25 minutes from the Budapest Airport
Team of professionals
We are a team of professionals with a strong record in pharmaceutical distribution. We build upon our deep understanding of medicine supply chains, strong processes & quality management, and expertise in relevant regulations.
Our service is the result of a collaboration between three companies with different profiles but all operating in the field of pharmaceutical logistics.
solDRA International – Drug Regulatory Administration Services
BetPharma – Pharma Logistics Services
Konzorcia – Serialization and IT Services
By joining forces, we can offer a comprehensive logistics portfolio and one-stop-shop service, allowing you to save time and energy for your business success!
Already Trusted Us
Years of Experience
Get In Touch
Ready to Get Started?
If you are interested in any of our services, write to us and we will contact you within 2 working days.