9 things to consider before starting a tech transfer
For global Regulatory Affairs Directors. A technology transfer can be the best decision for your manufacture – or, done wrong, it could be the worst. Our experts have identified 9 red flags to look out for before initiating a tech transfer. 1. No back-up manufacturing site Preferably, do not initiate a tech transfer unless a […]
Joint Scientific Consultation in the new EU HTA Regulation
With the new EU Health Technology Assessment (HTA) Regulation, significant changes are effective for Health Technology Developers (HTDs). One of the critical components of this new regulation is the Joint Scientific Consultation (JSC), a collaborative framework between HTDs and EU HTA bodies (HTAb) designed to streamline and enhance the clinical development of medicinal products and […]
Understanding Joint Clinical Assessment (JCA)
The evolving landscape of health technology assessment (HTA) in the European Union (EU) is characterised by a significant development: the introduction of joint clinical assessments (JCA) in 2025. This initiative, part of the new HTA regulation, aims to enhance efficiency, improve the quality of evaluations, and ultimately ensure that patients gain quicker access to innovative […]
Introduction to EU Health Technology Assessment Regulation (HTAR)
On the 12th of January 2025, the new EU Health Technology Assessment (HTA) Regulation (EU-HTAR) became effective. With the introduction of the EU-HTAR, pharmaceutical companies engaged in clinical trials have entered a new era of requirements and planning. This regulation aims to harmonise and streamline the assessment processes for health technologies across EU member states, […]
Keys to managing regulatory affairs in a global MAA project
Marketing authorisation application checklist for Global Regulatory Affairs Directors Planning and delivering pharmaceutical product approvals across regions globally is not an easy undertaking. Fortunately, at Arex Advisor we are experienced in multiple facets of the process. Below, we have listed some of the key factors to ensure success, and how to steer clear of common […]
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 […]
Knowledge: Costly pitfalls to avoid in drug development
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Knowledge: Top traits of brilliant regulatory consultants
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Knowledge: Managing RFIs for Clinical Trial Applications in CTIS
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