Importation and Warehousing
Pharmaceutical and biotech companies entering the European market face a critical strategic decision: establishing compliant supply chain infrastructure that enables product importation, storage, and distribution across EU member states. This initial market entry requires identifying suitable GDP-compliant warehousing facilities, securing sites authorized for physical importation, ensuring Qualified Person availability for batch release, implementing quality systems and operational procedures, qualifying logistics and warehousing partners, and navigating varying regulatory requirements across jurisdictions. Many organizations lack European market knowledge, struggle to evaluate facility capabilities and compliance status, face delays identifying partners who meet GDP standards, and risk costly mistakes selecting inadequate infrastructure that jeopardizes regulatory approval.
For decision-makers, establishing European supply chain infrastructure represents both significant investment and substantial risk. Selecting the wrong facility partner can trigger compliance failures, regulatory sanctions, product quality issues, and expensive remediation or relocation. The complexity of European regulations, combined with limited visibility into available options, makes independent facility selection challenging and time-consuming.
Our European Supply Chain Establishment services guide pharmaceutical and biotech companies through every step of building compliant importation and distribution infrastructure for their first entry into Europe. We leverage market knowledge, established industry relationships, and deep regulatory expertise to identify optimal facility solutions that match your operational requirements, budget constraints, and market strategy.
We begin by understanding your specific requirements: product characteristics and storage conditions, import volumes and growth projections, target markets and distribution scope, timeline and budget parameters, and preferred geographic locations. This assessment informs our facility search strategy and selection criteria.
We identify and evaluate potential warehousing partners who operate GDP-compliant facilities with appropriate capabilities. Our assessment examines facility design and environmental controls, temperature monitoring and validation status, security systems and access controls, inventory management technology, quality management systems and documentation, regulatory inspection history and compliance record, and capacity availability that accommodates your volume requirements.
We identify facilities authorized to serve as sites of physical importation, ensuring your chosen partner holds necessary customs authorizations, maintains appropriate import procedures, and can manage the complete customs clearance process efficiently.
We ensure Qualified Person services are available to perform mandatory batch release activities for imported medicinal products. This includes verifying QP qualifications and regulatory standing, confirming QP availability and capacity, and establishing clear procedures for documentation review and batch certification.
We conduct comprehensive due diligence on prospective facility partners, performing detailed capability assessments, reviewing quality systems and compliance documentation, conducting on-site audits when appropriate, and providing documented qualification reports that support your vendor approval process and satisfy regulatory expectations.
We support commercial negotiations with facility providers, helping you understand industry-standard terms, evaluate pricing structures, identify critical contract provisions, and secure favorable arrangements that protect your interests.
We guide the practical setup of your supply chain operations: developing Standard Operating Procedures for importation and storage, implementing quality agreements with facility partners, establishing inventory management and ordering processes, coordinating logistics and transportation arrangements, and preparing for initial product shipments.
We ensure your supply chain infrastructure aligns with all applicable regulatory requirements, including GDP guidelines, import licensing conditions, and Responsible Person obligations.
Establishing pharmaceutical supply chain infrastructure in Europe demands local expertise, industry connections, and regulatory knowledge that most organizations lack when entering the market for the first time. Our comprehensive establishment services transform this complex challenge into a managed process with predictable outcomes.
Contact us today to learn how our European Supply Chain Establishment services can accelerate your market entry and ensure compliant, efficient operations from day one.
