For non-European pharmaceutical companies, expanding into the European market is both an exciting opportunity and a formidable challenge. While the potential for growth is significant, so too are the complexities of achieving European marketing authorization. The regulatory, logistical, and cultural differences between European countries and countries outside of the region can hinder progress, increase costs, and delay time-to-market.
We understand these obstacles and offer a fully integrated solution to guide companies through every stage of the process—from regulatory strategy to market access and post-launch compliance.
Navigating the Complex European Regulatory Landscape
The Challenge: The regulatory structure and requirements of the EMA and national regulatory authorities within Europe vary across countries, but also significantly from those of the FDA, NMPA, TGA, ANVISA, and other regulatory authorities. With multiple pathways—including Centralised, Decentralised, Mutual Recognition, and National procedures—non-European companies often find the landscape difficult to interpret and navigate.
ProPharma's Solution: We provide tailored strategic guidance to determine the most appropriate regulatory pathway for your product. Our team ensures full alignment with EMA's and national European regulatory authorities' requirements, minimizing risks and accelerating timelines.
Meeting Stringent Data Requirements
The Challenge: European regulatory bodies frequently mandate different or additional data compared to the FDA or other non-European regulatory bodies. Non-European-based companies often need to adapt or supplement their data packages to meet EMA expectations.
ProPharma's Solution: Our experts perform comprehensive gap analyses and provide clear, actionable recommendations for addressing data deficiencies. We ensure your dossier is fully compliant and submission ready.
Managing Pre-Submission Activities and Procedural Support
The Challenge: Effective engagement with the EMA and national authorities prior to submission is crucial but unfamiliar territory for many non-European sponsors.
ProPharma’s Solution: We plan and facilitate all pre-submission activities, including scientific advice meetings. Our team manages documentation and represents your interests in regulatory discussions, ensuring consistency and professionalism throughout.
Ensuring Quality and Compliance
The Challenge: Complying with EU GMP, GDP, and GVP standards requires robust systems that align with European expectations—often different from models outside of the region.
ProPharma’s Solution: We help design, implement, and maintain quality systems that meet EU regulatory standards. Our support extends through inspection readiness and ongoing compliance monitoring and we can support you proving the necessary capacity to ensure product release and distribution.
Meeting Pharmacovigilance Requirements
The Challenge: Establishing an EU-compliant pharmacovigilance system, including appointing a QPPV and maintaining a Pharmacovigilance System Master File (PSMF), is a regulatory necessity—but a complicated one.
ProPharma's Solution: We provide end-to-end pharmacovigilance support—from QPPV appointment, writing a Summary of the PSMF to global literature search and RMP development. Our services ensure full alignment with EU safety requirements.
Securing Market Access and Reimbursement
The Challenge: While the clinical relative efficacy assessment will be handled more jointly on a European level through the health technology assessment (HTA) regulation, each European country still has its own approach to pricing and reimbursement, adding layers of complexity to market access planning.
ProPharma’s Solution: We develop European and country-specific market access strategies, guiding you through joint clinical assessment (JCA) and HTA submissions, price negotiations, and reimbursement approvals to optimize your product’s market uptake.
Managing Logistics and Supply Chain
The Challenge: Building a compliant EU supply chain—including MIA acquisition and Qualified Person (QP) release—is a major undertaking for non-European companies.
ProPharma’s Solution: With our MIA in place, we can act as your QP and provide the necessary declaration for your submission. We also consult on broader supply chain considerations, ensuring a smooth path to commercial distribution through our team of Responsible Persons (RPs).
Bridging Cultural and Language Gaps
The Challenge: Miscommunication can lead to regulatory delays or misunderstandings. Cultural nuances and language barriers must be handled with care.
ProPharma’s Solution: Our multilingual experts ensure accurate communication, offering linguistic and cultural consulting services that foster productive engagement with European stakeholders.
Streamlining the Entire Process
The Challenge: Managing all these moving parts—regulatory, pharmacovigilance, quality, market access, and logistics—can overwhelm even well-resourced companies.
ProPharma’s Solution: We act as your single point of contact, integrating all services under one roof. Our coordinated approach streamlines workflows, reduces friction, and accelerates your path to authorization.
Your Trusted Partner for European Success
At ProPharma, we don’t just offer services—we become a strategic extension of your team. With deep expertise across the entire product lifecycle and a proven track record in the European regulatory space, we empower companies to successfully bring their products to the European market with confidence.
Let us help you simplify complexity, accelerate timelines, and achieve successful market entry in Europe.
