Particulate Risk Investigation and Root-Cause Resolution
Container Closure and Product-Package Integrity
- Cryogenic Packaging & Transport Simulation Studies
- Vacuum Decay Studies
- MicroCurrent High Voltage Leak Detection (HVLD)
- Laser-Based Gas Headspace Analysis
- Vials, Syringes, Cartridges, & Difficult Configurations
- Custom Method Development and Validation Across Multiple Platforms
- “Which CCIT Method Fits My Package?” use-case page
Visible & Subvisible Particle Characterization: Beyond Compendial Counts
Parenteral Packaging Functional Suitability
Biologics & Protein Therapeutics
Flow Imaging Microscopy (FIM/MFI) and orthogonal testing to instantly separate protein aggregates from silicone oil and foreign debris. By tracking particle morphology across formulation and packaging changes, we give you the technical clarity to de-risk development and satisfy regulatory scrutiny.
Sterile Injectables & Parenteral Manufacturers
Gateway delivers rapid, definitive particulate identification, complaint investigation support, and root-cause resolution alongside cGMP USP particulate testing to keep your operations moving. Paired with deterministic Container Closure Integrity Testing (CCIT) and USP <382> functional suitability evaluations.
Advanced Therapies (Cell & Gene Therapy)
Gateway specializes in low-volume particulate investigations, single-use component evaluations, and cryogenic container performance studies tailored to this evolving regulatory landscape.
Solving Drug Product Risks with Gateway Analytical. Applying Lifecycle Quality Risk Intelligence.
At Gateway Analytical, we apply Lifecycle Quality Risk Intelligence to connect analytical evidence across your entire product journey—combining rapid root-cause particulate identification, deterministic container closure integrity, subvisible particle characterization, and functional suitability testing.
By translating isolated laboratory data into long-term product understanding, we give your quality, operations, and regulatory teams the technical clarity and scientific proof needed to mitigate risk, resolve deviations, and release product with total confidence.
Technical Documentation & Resources
Connecting Analytical Evidence Across Your Drug Product Journey
By bridging our four core service areas: Particulate Investigations, Container Closure Integrity, Subvisible Characterization, and Functional Suitability—we transform routine laboratory data into deep product understanding, investigation readiness, defect prevention, and total regulatory confidence.
Beyond One-Off Testing: Lifecycle Quality Risk Intelligence
Accelerating Medicine Your Journey Tomorrow Together
At Gateway Analytical, we specialize in providing innovative solutions tailored to the unique challenges of our clients in pharmaceutical & healthcare industries. Our team of expert scientists and analysts are committed to delivering accurate, reliable, and actionable insights that help our clients achieve their goals and advance their research. 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.
With decades of expertise on the pathway of pharmaceutical drug development, our mission was to establish a full-service analytical laboratory that stands apart in excellence. Proudly, we’ve earned recognition through audits and certifications from institutions like the U.S. Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (DEA), the International Organization for Standardization (ISO), Health Canada, and the European Medicines Agency (EMA). These accolades reflect our deep commitment to delivering unparalleled quality, ensuring safety, and adhering to stringent regulatory standards.
Gateway Analytical: Your Partner in Precision
Precision Analytical Testing for Early-Phase Pharmaceuticals & Medical Devices
We’re not just an FDA-registered & DEA-licensed, cGMP-compliant laboratory; we’re your partners in innovation and safety. With over a decade of expertise in parenteral testing, we cover a broad range of services from process and formulation development, product-package validation, clinical & commercial manufacturing, to visual inspection, quality control, release testing, advanced chromatography techniques & beyond.
Our lab provides specialized analytical testing solutions for injectable, biologic, sterile injectable, parenteral, and advanced-therapy companies around the globe. Our expertise spans particulate investigation, container closure integrity, subvisible particle characterization, packaging component functional suitability, and lifecycle quality risk, helping customers support release, regulatory, investigation, commercialization, and lifecycle decisions with confidence.
Particulate Risk Investigation and Root-Cause Resolution
Identify, characterize, and trace microscopic contaminants to source using high-resolution spectroscopy and forensic microscopy.
Container Closure and Product-Package Integrity
Ensure sterile barriers with physical-chemical testing, verifying tight seal boundaries and critical container-closure interfaces.
Visible & Subvisible Particle Characterization
Dig deeper than basic quantitative limits. Understand precise material chemistry and morphology of foreign entities in real context.
Parenteral Packaging Functional Suitability
Evaluate interaction of formulation with glass and elastomeric systems, ensuring maximum performance stability over the product lifecycle.
Lifecycle Quality Risk Intelligence
- cGMP Compliant & FDA Registered Laboratory Facilities
- Specialized in Particulate Identification & Material Characterization
Leverage analytical evidence to make better product-quality decisions across drug product development, commercialization, investigations, supplier/component changes, complaints, and regulatory obstacles with Lifecycle Quality Risk Intelligence from Gateway Analytical.
Biologics & Protein Therapeutics
Flow Imaging Microscopy (FIM/MFI) and orthogonal testing to instantly separate protein aggregates from silicone oil and foreign debris. By tracking particle morphology across formulation and packaging changes, we give you the technical clarity to de-risk development and satisfy regulatory scrutiny.
Sterile Injectables & Parenteral Manufacturers
Delivering rapid, definitive particulate identification, complaint investigation support, and root-cause resolution alongside cGMP USP particulate testing to keep your operations moving. Paired with deterministic Container Closure Integrity Testing (CCIT) and USP <382> functional suitability evaluations.
Advanced Therapies (Cell & Gene Therapy)
Gateway Analytical specializes in forensic particulate investigations, single-use component evaluations, and cryogenic container performance studies tailored to the ever-evolving regulatory compliance landscape.
Ready to Secure Your Lifecycle Quality?
Start your investigation today and move from isolated methods to strategic pillars.
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.