The Medicine Maker | Quality & Compliance

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Bioprocessing Interviews Regulation & Standards Standards & Regulation Quality & Compliance Technology & Manufacturing Sponsored

Moving Beyond Document-Based Validation

July 2, 2026

How UCB is improving traceability, audit readiness, and visibility.

1 min read

Bioprocessing Interviews Technology & Manufacturing Digital Technologies Quality & Compliance Regulation & Standards Sponsored

How Zealand Pharma Is Scaling Quality Without Complexity

June 29, 2026

How connected quality systems can help growing biotechs remain agile.

0 min read

How Zealand Pharma Is Scaling Quality Without Complexity

Regulation & Standards Supply Chain Interviews

Innovating Pharmaceutical Packaging

March 25, 2025

Michiel van den Berg sheds light on the challenges and opportunities facing the industry as it adapts to new materials and regulatory requirements, offering expert insights into the future of pharmaceutical packaging.

3 min read

Cell & Gene Bioprocessing Biopharma Formulation Outsourcing Technology & Manufacturing

AI Approach to Transdermal GLP-1s

February 25, 2025

How do you design, refine, and optimize novel GLP-1 drugs that could improve patient experiences? With a computer, of course.

3 min read

Formulation Regulation & Standards Small Molecules

Using the Right Excipients to Mitigate Nitrosamine Formation

By Anne-Cécile Bayne

January 21, 2025

In 2018, nitrosamines were discovered in some pharmaceuticals. The industry has since been under pressure to reduce the risks in both in-development and on-market drug products.

3 min read

Using the Right Excipients to Mitigate Nitrosamine Formation

Regulation & Standards Business & Trends

EFPIA Calls For Clarity Over JCA Concerns

By Rob Coker

December 20, 2024

EU-based associations voice concerns over joint clinical assessments and the lack of advice meetings.

2 min read

EFPIA Calls For Clarity Over JCA Concerns

Facilities & Equipment Technology & Manufacturing Regulation & Standards

AI and the Copyright Question for R&D

By Rob Coker

December 17, 2024

A Pistoia Alliance survey looks at stakeholder concerns in AI regulations, and calls for more harmonization and collaboration.

2 min read

Facilities & Equipment Technology & Manufacturing Regulation & Standards Business & Trends Interviews

Ambition, Innovation, Impact: The Future of Cleanroom Standards

December 4, 2024

The rocket-fueled dreams of a young engineer applied to the cleanroom industry. Sitting down with Kevin Kyle, CEO, Germfree, who shares insights on the dynamic landscape of cleanroom design and deployment.

5 min read