SANNZ Regulatory

About SANNZ Regulatory

We offer expert EU Regulatory Affairs Strategy and Project Management services. With a proven track record, we bring a wealth of experience to the table, having collaborated with industry leaders like AMGEN, CHUGAI, and DAIICHI-SANKYO in various mid to senior-level roles. Our Services: Regulatory Submissions Strategy: Specialise in spearheading project management initiatives, meticulously crafting regulatory submissions strategies for small and large molecules. Our expertise spans Marketing Authorisation Applications (MAA), Paediatric Investigation Plans (PIP), Scientific Advice, and Orphan Drug Designations (EU ODD). Effective Project Management: Seamlessly integrating regulatory affairs with project management, we excel in planning, preparing, and delivering submission timelines throughout the product's life cycle. Our approach involves utilising standard methodologies in a dynamic environment, ensuring efficient project execution. Global Regulatory Strategy: Acting as your dedicated global regulatory strategy lead, we focus on early development for oncology and rare diseases, particularly monoclonal antibodies (mAbs), contribute to clinical development plans, regulatory strategy documents, and skilfully navigate regulatory landscapes. Compliance and Health Authority Interaction: Ensuring compliance is at the core of our services, we provide expert input on procedural and documentation requirements defined by Health Authorities whilst also proactively leading scientific advice with Central and National EU Health Authorities to cultivate positive regulatory relationships. Project Lifecycle Management: From project initiation to post-marketing activities, [Your Company Name] plays a pivotal role in managing assets in early development. We expedite critical initiatives, including First-in-Human studies, Orphan Drug Designations, and Paediatric Investigation Plans.

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