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Regulatory Updates

The QbD Group regulatory updates blog provides professionals in the life sciences with timely and insightful information on the latest regulatory trends, guidelines, and compliance requirements. Covering topics from pharmaceutical manufacturing standards to medical device approvals, the blog aims to support readers in navigating complex regulatory landscapes, ensuring product safety, and accelerating time to market. Whether you're involved in quality assurance, regulatory affairs, or product development, this blog offers valuable resources to keep you informed and compliant.

Regulatory Updates

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New Q&A on the obligation to inform in case of interruption or discontinuation of supply

First Revision of MDCG 2021-25 Released

MDCG 2024-12 released

MDCG 2024-11 released

Newly Listed Harmonized Standards

Revised MDCG 2021-4 Guidance Documents Released

The FDA releases revision of guidance regarding Control of Nitrosamine Impurities in Human Drugs

New MDCG Guidance Documents Released

Publication of Amendments to Regulation (EU) 2024/1860

MDCG: First Revision on the Guidance on Standardisation for Medical Devices

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Events calendar

Industry
Service

January

28.01 - 29.01

Clinical

OCT Medical Devices Europe 2025

Munich, Germany

February

02.02 - 06.02

Regulatory Affairs

Medlab Middle East 2025

Dubai, United Arab Emirates

March

11.03 - 12.03

Regulatory Affairs

RAPS Global Regulatory Strategy Conference 2025

Baltimore, Maryland, USA

May

13.05 - 16.05

Regulatory Affairs

RAPS Euro Convergence 2025

Brussels, Belgium
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