Scendea is proud to announce our partnership with CUES Consulting, specialists in Japanese regulatory affairs, safety management, and post-marketing surveillance.

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 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.

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.

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.

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.

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.

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.

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.

Drug-device combinations (DDCs) are products that include both a medical device and medicinal product constituent part. There are two main types of combination products: Integral and Co-packaged.

Successful approval of biological medicinal products in the EU and US require characterisation of biological products’ properties to enable the setting of specifications that control the molecule’s critical quality attributes (CQA) for release into the clinic and onto the market.

Click to read BDO’s latest published whitepaper in collaboration with the team here at Scendea.