Technical articles
30/04/2026
Major Evolutions of EU GMP Chapters 1 and 4: Towards a Reinforced Governance of Quality, Data, and Knowledge
European regulatory authorities have initiated a revision of Chapter 1 (Pharmaceutical Quality System) and Chapter 4 (Documentatio
16/04/2026
Design Transfer according to ISO 13485:2016: From Development to Medical-Device Production
Design and development, which culminate in design transfer, are pivotal stages in the life cycle of a medical device.
19/03/2026
Reimbursement of Health Products in France: A Public-Health and Market-Access Issue
This article provides a concise overview of the reimbursement dossier journey, outlining its stakes, the key stakeholders involved
5/03/2026
The Talc Debate: Health Risks and Controversies
A seemingly harmless natural mineral, talc has once again become the focus of a major public-health debate in 2025
19/02/2026
Post-Marketing Authorisation Variations: The changing European regulatory landscape, from regulation to guidance
As of 15 January 2026, the European framework for managing post-marketing authorisation (MA) variations for human medicinal produc
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8/01/2026
Behind every Smart AI is smarter Data Management
Artificial Intelligence (AI) is reshaping industries, influencing decisions from medicine to transportation, finance to entertainm
13/11/2025
U.S. Government Shutdown: Consequences for manufacturers and strategic mitigation measures
The U.S. government shutdown has forced multiple federal agencies, including the FDA, to operate with limited resources.
6/11/2025
Thresholds of Toxicological Concern (TTC)
The toxicological risk assessment of a device’s constituents (ISO 10993-17) relies on data obtained either through chemical char
25/09/2025
The evolution of the european regulatory framework regarding electronic instructions for use (EIFU) of medical devices: analysis of regulation (EU) 2025/1234 amending regulation (EU) 2021/2226
Since the adoption of Regulation (EU) 2017/745 on Medical Devices, the European Commission has embarked on a modernization effort
11/09/2025
CLP, REACH and PPWR: Toward Strategic Regulatory Convergence to Support Sustainable Innovation in Life Sciences
The European Union (EU) is undergoing a major overhaul of its strategy on chemical safety, product traceability and environmental
24/07/2025
ECHA accelerates the transition towards animal-free chemical evaluations
The ECHA is announcing its commitment to drastically reduce, and then eliminate, animal testing.
3/07/2025
Unlocking the Potential of Comparative Genomics in Bacterial Research
This article explores the key steps and methodologies in bacterial comparative genomics.
