Press Releases
Curiosity + Expertise = Innovation.
Catch up on all the latest Gateway Analytical news and press releases, see a list of events we’ll be attending, and read our original content discussing our latest services offerings and instruments in the articles below.
Forensic Particulate Investigations: Navigating Quality Control Obstacles
When Quality Control (QC) identifies an unknown particle during fill-finish or inspection, it isn’t just a deviation, it’s a critical event. For developers of CGT,
PDA Week 2026 Recap: Advancing Particulate Science, CCI Strategy, and Regulatory Readiness
As PDA Week 2026 comes to a close, our team is returning from Denver energized by the insights, conversations, and collaborations we shared with global
Live at PDA Week 2026: Visit Gateway Analytical at the Aptar Pharma Exhibit
PDA WEEK – DENVER, CO – MARCH 2026 We’re here live at PDA Week 2026 in Denver, where global leaders in sterile manufacturing, quality, and
Gateway Analytical and Aptar Pharma Prepare to Showcase Integrated Drug Delivery & Analytical Solutions at PDA Week 2026
PDA WEEK – DENVER, CO – MARCH 2026 Gateway Analytical is proud to attend the 2026 PDA Annual Meeting Week in Denver, Colorado alongside our
Gateway Analytical Prepares for PDA Week 2026: Let’s Talk Particulates, CCI, and 2026 Regulatory Readiness!
Are you attending PDA Week 2026, the industry’s premier gathering for leaders in sterile manufacturing, pharmaceutical quality, and regulatory science? From March 23-25, Gateway Analytical
Forensic Particulate Investigations: Navigating Quality Control Obstacles
When Quality Control (QC) identifies an unknown particle during fill-finish or inspection, the deviation represents a critical path event. For developers of CGT, ATMPs, and
Closing the USP <1790> Gap: Demonstrating Inspection Adequacy for DIPs
As we face the new regulatory landscape of 2026, standard 100% visual inspection is no longer sufficient to meet regulatory scrutiny. During a BLA review
The Gateway Analytical Journal – Monthly Roundtable – Issue 01 // January 2026
Welcome to the Gateway Analytical Monthly Technical Briefing! Every month, we’ll bring you the latest on evolving regulatory expectations, upcoming industry events, and key insights
Beyond Compliance: Navigating the Future of USP <382> and <661>
With the 2025 regulatory deadlines now firmly established as the baseline, 2026 represents a shift from compliance to system-level optimization. For organizations developing and manufacturing
USP <382> Is Now in Effect. Here’s What Your Team Needs to Do Next.
As of December 1, 2025, USP <382> is officially in effect and teams across the industry are now navigating the requirements for system-level functional suitability
Are Your Drug Products Ready for the December 1st, 2025 USP <661> Deadline?
The clock is ticking! The compliance deadline for USP <661.1> and <661.2> is approaching quickly, and every day truly matters. These crucial updates are set
Key Takeaways & FAQs from Our Webinar: USP <382> Deadline Readiness
With the USP <382> deadline still fast approaching on December 1, 2025, our recent webinar made one thing clear: teams are taking action. The urgency
USP <382> December Deadline. Compliance Starts Here
Last call to secure your seat today! Get ahead of upcoming regulatory deadlines! Join Gateway Analytical tomorrow, October 21st for our exclusive webinar, where we
*Upcoming Webinar* USP <382> & Annex 1: Converging Standards for Sterile Packaging Compliance
Save your spot today and gain a roadmap to compliance and inspection readiness. Join our webinar on Tuesday, October 21, 2025, where our experts from
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
Empowering Your Journey Toward Enhanced Patient Care
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.