Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

A Shift Towards Biofluorescent Particle Counters In Manufacturing
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
Accelerate And Enhance Biomanufacturing Operator Training
Unlock the power of blended operator training and learn how combining digital tools with hands-on instruction reduces errors, boosts retention, and empowers your workforce for real-world production success.
Sustainable Vaccine Manufacturing: Securing The Future Of Global Health
Explore how next-gen technologies, from mRNA platforms to digital tools, are transforming vaccine manufacturing to make it more sustainable, flexible, and accessible.
EU GMP Annex 1 Compliance: Global Requirements And PIC/S Alignment
The 2023 revision of EU GMP Annex 1 resets the global standard for sterile manufacturing. Learn what’s changed and how PIC/S alignment extends these requirements to many non-EU markets.

Closed Sampling: Crucial For Aseptic Processing
6/26/2025

Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.
Join Us At Summit CXO
8/14/2025

Join top life sciences executives at Summit CXO, October 6–8 in Salt Lake City, for exclusive insights, expert speakers, and powerful networking that will elevate your leadership and strategic impact.
Sample Preparation Automation For Immunosuppressant Drug Analysis
10/10/2025

Discover how automated sample prep for immunosuppressant drug analysis improves accuracy, reduces contamination, and streamlines LC-MS/MS workflows.
Enhancing Viral Vector Sterile Filtration: Process Efficiency And GMP Alignment
11/4/2025

Explore filtration strategies that improve viral vector yield and quality, with insights on AAV and lentivirus workflows, plus practical guidance for implementing PUPSIT in line with requirements.
Designing Robust Studies To Meet Auto-Injector Performance Requirements
10/30/2025

Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.

Instrument For Accurate Filter Integrity Testing

The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.
Highly Potent And Complex API Contract Manufacturing

Equipped with a diverse array of scales, our seasoned experts possess the finesse and acumen necessary to tackle even the most intricate and potent API projects.
Two Decades Of Sterile Manufacturing Excellence

Ensure the highest quality and sterility for your injectable manufacturing with proven aseptic expertise. Expect customer-first service, regulatory excellence, and a commitment to long-term success.
Process Challenge Device (PCD®) Selection Guide

Explore how standardized PCDs improve sterilization reliability, reduce costs, and support regulatory compliance, as well as technology that offers more consistent EO sterilization validation.
Meet Regulatory Guidelines In GMP/GLP Labs With SoftMax Pro GxP Software

Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation

SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.