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.
Beyond USP <788> Compliance: Is Your Method Suitability Defensible for 2026?
With new regulatory expectations for 2026 well underway, compliance for method suitability and defensibility continue to shape clinical drug development. Staying ahead of these evolving
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
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Medical Device
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Extractables
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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.