Drug Registration
Navigate the European Drug Registration Process with Expert Support
At AZB Consulting, we specialize in guiding pharmaceutical companies through the complex process of drug registration in Europe. Whether you are introducing a new therapy or expanding your portfolio, our experts provide customized, strategic support to secure timely and successful marketing authorizations across the European Union (EU)/European Economic Area (EEA), Switzerland (CH) and the United Kingdom (UK).
Our deep regulatory intelligence, combined with extensive hands-on experience with the European Medicines Agency (EMA) and national competent authorities, ensures a proactive, efficient, and compliant path to approval.
Our services include regulatory strategy, pre-submission meetings, submission planning &, risk assessments, gap analyses and due diligence. We provide advice to ensure you’re always one step ahead of agency expectations.
Our Expertise
Navigate the European Drug Registration Process with Expert Support.
At AZB Consulting, we offer a comprehensive suite of regulatory services to guide your product through successful registration in Europe. We provide strategic and operational expertise to streamline your product’s journey to approval across Europe, Switzerland, and the United Kingdom.
Registration Strategy
We design customized regulatory strategies that align with your product’s development stage, therapeutic area, and commercialization goals. Our experts build efficient roadmaps, integrating pre-submission meetings and national, centralized, decentralized, and mutual recognition procedures to optimize your pathway to market authorization across the European Union (via EMA), Switzerland (via Swissmedic ) and the United Kingdom (via MHRA ).
CTD Writing and Publishing
We manage document authoring and prepare high-quality, submission-ready Common Technical Document (CTD) modules that meet the rigorous standards of European regulatory authorities, ensuring your submission is complete and compliant. We publish and submit the dossier following the EMA – CTD Guidance Swissmedic – Dossier Requirements and MHRA – Marketing Authorisations.
Management of Registration Procedures
We manage all aspects of the registration process, coordinating centralized procedures (EMA Centralised Procedure ), decentralized and mutual recognition procedures (CMDh – Coordination Group) and national procedures through Swissmedic and MHRA.
Product Information and Labelling
We develop, review, and manage your product information, including Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labelling, including the coordination of the linguistic review process for the centralized procedure, ensuring compliance with: EMA – Product Information Templates (QRD), Swissmedic – Information for Healthcare Professionals and Patients , MHRA – Packaging, labelling and patient information leaflets.