Bringing a new therapy to market requires global oversight and local precision. Our Regulatory Affairs team combines worldwide intelligence with deep national expertise to guide products from marketing authorization application through long-term lifecycle management.
We provide regulatory consulting and hands-on support for Marketing Authorization Applications (MAA) in the EU, New Drug Applications (NDAs) and Biologics License Applications (BLAs) in the US as well as applications in other key markets worldwide. Our specialists prepare regulator-ready dossiers, coordinate with health authorities and adapt submissions to meet the precise requirements of each jurisdiction. Whether through centralized, decentralized, mutual recognition, or national procedures, we ensure applications are technically sound, compliant and strategically aligned to accelerate approvals.
Our support extends far beyond the initial authorization. We deliver comprehensive post-approval lifecycle services designed to maintain compliance and sustain market access.
This includes managing variations, renewals, safety-driven changes, labeling updates and continuous product information maintenance. By leveraging our established network of local experts, we provide direct, in-market support – from adapting documentation and labeling to liaising with authorities – ensuring your product remains compliant, inspection-ready, and consistently available to patients worldwide.
