In the 2026 regulatory environment, a “pass/fail” result for subvisible particulate matter is only the beginning. For injectable and parenteral drug products, the focus has shifted toward method verification, the proof that your analytical procedure is suitable for your specific drug formulation and container.
Gateway Analytical provides specialized Method Verification Consults to help teams navigate the requirements of USP <787>, <788>, and <789>. We focus on the “Lifecycle Sweet Spot” where products are regulatorily exposed, ensuring your data stands up to FDA, EMA, or Health Canada review.
Our consult focuses on:
Modality-Specific Verification: Tailoring methods for high-risk and non-standard modalities where standard light obscuration may be inadequate.
Analytical Rigor: Establishing verified methods for compendial release and stability that exceed generalist CRO capabilities.
Filing Robustness: Creating technical documentation that provides regulatory confidence during BLA/NDA submissions.
When standard methods aren’t scientifically defensible, we provide the specialized testing required to protect your regulatory timeline.
Curious about next steps? Interested to learn more about our process and toolkit at Gateway Analytical? Schedule your call, or use our Interactive Sample Submission Form here: https://gatewayanalytical.com/contact-us/
Gateway Analytical — Scientific Clarity for Complex Problems.
