We provide comprehensive EU regulatory affairs services for pharmaceutical companies navigating the European regulatory landscape. We guide your products from Marketing Authorization Application through post-approval lifecycle management — with precision, speed, and full compliance.
Specialized in the CEE region, we manage national (NP), mutual recognition (MRP), and decentralized (DCP) procedures, ensuring smooth authority interactions and sustainable market access across Europe.
Our services include, among others
We prepare and maintain high-quality marketing authorization applications (MAA) in CTD and eCTD format for national, decentralized (DCP), mutual recognition (MRP), and centralized procedures. Our regulatory experts ensure full compliance with EU pharmaceutical legislation while optimizing submission timelines and approval success rates across European markets.
We manage all post-approval regulatory activities, including Type IA, IB, and Type II variations, renewals, sunset clause management, and labeling updates. Our team supports CMC documentation updates to maintain regulatory compliance and ensure uninterrupted product supply within the EU.
We develop tailored EU regulatory strategies aligned with your product development and commercialization goals. Acting as your regulatory partner, we manage communication with national competent authorities and the European Medicines Agency (EMA), prepare scientific justifications, and coordinate responses to regulatory questions efficiently and professionally.
We provide comprehensive lifecycle management for medicinal products authorized through national, MRP/DCP, and centralized procedures. Our proactive regulatory oversight minimizes compliance risks, supports sustainable market presence, and ensures long-term portfolio stability in Europe.
Our pharmaceutical regulatory consulting services cover full procedure management across EU member states. From submission planning to approval and post-authorization follow-up, we ensure harmonized documentation and smooth coordination between stakeholders and health authorities.
We continuously monitor evolving EU pharmaceutical regulations, guidelines, and authority expectations to keep your product portfolio compliant. Our regulatory intelligence services help anticipate legislative changes, mitigate risks, and support strategic decision-making in a dynamic regulatory environment.
We review packaging materials, SmPC, PIL, and labeling components to ensure alignment with approved dossiers and current EU regulatory standards. Our detailed artwork compliance checks reduce the risk of authority objections and support successful product launches.
We provide Local Marketing Authorization Holder (MAH) representation services within the European Union. Acting as your reliable regulatory contact point, we ensure ongoing compliance with EU requirements and maintain effective communication with health authorities on your behalf.
Our phone number
+421 948 445 762
Our e-mail
office@biodrug.net
