Our Articles
Explore our thought leadership article library, where you can find a wealth of insights on regulatory intelligence, industry updates, and the latest pharmaceutical and biotechnology developments.
Scendea announces strategic partnership with CUES Consulting
Scendea is proud to announce our partnership with CUES Consulting, specialists in Japanese regulatory affairs, safety management, and post-marketing surveillance.
Australian R&D Cashback & Early Development Activities
With demand for improved healthcare increasing globally, Australia is continuing to emerge as an attractive destination for the development of new and improved drugs and medical devices, driven by excellent research capabilities, a favourable Therapeutic Goods Administration (TGA) regime and an attractive Research and Development Tax Incentive (RDTI) regime.
Scendea Ltd Achieves a Prestigious King’s Award for Enterprise.
Scendea Ltd is proud to announce it has received a King’s Award for Enterprise for International Trade 2024. This prestigious award recognises Scendea’s outstanding growth in international trade.
Regulatory Roadmap & Key Considerations for Executives Building a Clinical-Stage Company
The pathway for transitioning into a clinical-stage company is a crucial step in the development lifecycle of a product, as a favorable safety profile needs to be demonstrated and regulatory approval received before embarking on first in human clinical studies.
Managing Drug Safety in the EU: From Clinical Development to Marketing Authorisation Submission
Patient safety is at the centre of drug development and monitoring the safety profile of a drug from the first patient dose through to market and beyond is a key activity for all drug developers.
Immunogenicity of Innovative and Biosimilar Medicinal Products
The first regulation and guidance for copy biotech products (biosimilars), pioneered by the EMA, not only enabled the introduction of biosimilars in the EU, but also were a model for regulatory regions worldwide.
Microbiome Medicinal Products: Concept to Commercial
A growing body of pre-clinical and clinical research has implicated the influence of bacteria on human health which over the last decade led to a flurry of venture capital and biopharma interest.
Clinical Trial Regulation: A New Chapter for EU Clinical Trials
We are thrilled to announce the release of our new whitepaper, in collaboration with FGK, "Clinical Trial Regulation: A New Chapter for EU Clinical Trials", authored by Senior Consultant, Amy Cooke, Principal Consultant, Dr Maria Beatrice Panico, and Director of Regulatory Affairs at FGK, Dr Uwe Kramer.
The Importance of Regulatory Strategy
Getting a new drug to the patient involves numerous stakeholders that are part of a multi-faceted regulatory framework. This framework has evolved over time and proceeds from drug discovery to development to regulatory evaluation.