Efor news
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.
2/04/2026
Nitrosamine Impurities in Pharmaceuticals: Chemistry, Evolving Regulations and Strategic Risk Control
Nitrosamines are highly reactive, potentially DNA-damaging chemicals
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
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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
5/02/2026
Risk-Based Monitoring and the impact of ICH E6 (R3) on clinical trials
Revision 3 of the Good Clinical Practice guideline (ICH E6 [R3]) was adopted on 6 January 2025 and will take effect on 23 July 202
22/01/2026
Clinical Data Management: The Art of Managing Clinical-Trial Data
This article delves into the fundamentals of Clinical Data Management and shows why it is essential to the success of today’s sc
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
25/12/2025
Digitalization: Transforming processes to accelerate innovation in Life Sciences
Digitalization has become a crucial strategic lever for companies in the life sciences sector. It involves transforming objects, p
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
