CMC in a global MAA project – what to keep on your radar
Marketing authorisation application checklist for Global Regulatory Affairs Directors Our MAA services The CMC section of the regulatory dossier stands as one of the cornerstones for achieving a successful global MAA for pharmaceutical products. Regulatory Affairs Directors must often navigate a labyrinth of requirements to ensure compliance across diverse markets, while maintaining the highest standards of […]
A guide to labelling in global MAA projects
Marketing authorisation application checklist for Global Regulatory Affairs Directors Effective labelling is not just a regulatory necessity, it’s essential for patient trust and product success. In this article, we aim to share valuable insights on vital labelling considerations, common pitfalls, and best practices to help guide you toward a seamless MAA/NDA/BLA experience. Related articles:Keys to […]
Press release: Medical device specialist joins Arex Advisor
Stockholm, Sweden Arex Advisor AB are pleased to welcome medical device specialist Callum Kitson-Parker to the team. Callum brings valuable knowledge in outsourced medical device development and manufacturing projects, as well as extensive experience in quality management, regulatory submissions and product registrations (IVDR/MDR/FDA/PMDA/UKCA). “Callum’s deep and diverse experience in medical device development stands out in […]
Knowledge: Costly pitfalls to avoid in drug development
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Knowledge: Top traits of brilliant regulatory consultants
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News: Arex Advisor 2023 in words and numbers
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