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GxP Compliance

The Pharmaceutical Industry’s Path to Sustainable Development

This article covers the pharmaceutical industry's push for sustainability through ethical sourcing, innovation, and supply chain challenges.

Artificial Intelligence

The Role of the Quality Professional in the Evolution of AI in BioPharma and Medical Devices

AI is transforming biopharma—learn its impact on Quality professionals and why preparation starts now.

Annex 1

New GMP Annex 1: How to Stay Ahead in Sterile Manufacturing

Stay ahead with the new EU GMP Annex 1—discover key updates on QRM, CCS, and cleanroom monitoring for compliance and product safety.

GxP Compliance

Embracing Paperless Validation in a Fast-Evolving Life Sciences Industry

Embrace paperless validation to streamline workflows, enhance compliance, and reduce costs while meeting evolving regulatory standards in life.

Commissioning, Qualification and Validation (CQV)

Why Equipment Qualification & Validation are Non-Negotiable in Life Sciences

Equipment Qualification & Validation: essential for quality, safety, and compliance in Life Sciences manufacturing

Artificial Intelligence

Why Life Sciences Needs Responsible AI use with Human Validation

Learn how AI validation, ethics, and oversight ensure safe, effective AI in life sciences under the EU AI Act.

Regulatory Affairs

IVDR: What Does It Mean for Manufacturers of In Vitro Diagnostic Devices?

The transition to IVDR introduces new challenges for IVD manufacturers, with stricter requirements and revised timelines to ensure compliance

Pharmacovigilance

EMA's 2025 Benefit-Risk Guidelines: Impact on Veterinary Medicine

Discover what the EMA’s updated benefit-risk guidelines for veterinary medicine mean in 2025 and how they impact manufacturers, veterinarians, and.

Clinical Research

Why Small Pharma Companies Rely on CROs and What They Expect

Small pharma companies rely on CROs for expertise, cost-effectiveness, flexibility, and strong communication in clinical trials.

IT Operations

The Challenges of Operating System Obsolescence in the Pharmaceutical Industry

Challenges of OS obsolescence in pharma: cybersecurity risks, compliance issues, and the need to migrate from Windows 10 to ensure security and.