Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

4 Conversations To Drive Your Business Case For Digital Validation
Change in life sciences is challenging due to strict regulations, high stakes, and the importance of patient safety. Learn how to advocate for digital validation workflows through four key conversations.
Lessons From FDA 483s And Warning Letters: Cleanroom Compliance
Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
A Simple Method For Cell Growth Media Preparation
Explore how powder media and sterile fluid handling can reduce contamination risk and improve efficiency in viral vector production, especially for HEK293-based AAV workflows.
ICH Q12 Implementation: Regulatory Intelligence And PACM Agility
Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

Client Story: Efficiency Enabling CSV At Scale
7/1/2025

Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.
Qualicaps Virtual Pharma Expo September 2025: Oral Solid Dose Manufacturing And Packaging
9/18/2025

Explore how a new capsule inspection system helps manufacturers overcome labor shortages, increase throughput, and maintain quality while meeting global compliance standards.
It's Time To Intensify
8/7/2025

The biopharmaceutical industry is evolving fast, which is pushing manufacturers to cut costs and boost productivity. Discover how process intensification can streamline operations and secure your future.
Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques
2/26/2025

Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.
Efficient Pathways: The Regulatory Edge Of New Zealand For Pharmaceutical Development
7/29/2024

By leveraging the country's regulatory advantages and partnering with a New Zealand-based CDMO, international companies can accelerate approvals and navigate the regulatory pathway with ease.

Setting New Standards In Active Air Monitoring

By combining proven performance, refined data handling and smart features, the MAS-100 Sirius® air sampler makes active air monitoring in high-grade cleanrooms more reliable and convenient than ever before.
Top 10 Reasons To Move From On-Premise Systems

Discover how cloud migration enhances security, scalability, and innovation while reducing IT burden to streamline workflows, boost collaboration, and ensure regulatory compliance.
The Future Of Glass Packaging Is Here

Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.
All-In-One Process Raman Analyzer

The Thermo Scientific™ MarqMetrix™ All-In-One Process Raman Analyzer is a compact and portable Raman spectrometer all-in-one system with patented technology, purpose-built for rapid deployment, ease-of-use, and flexible scalability in markets where time-to-results is key.
Software To Automate And Digitalize Data Recording Steps In QC Workflows

Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.