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
Scientific Clarity for Complex Materials Challenges
Accredited Analytics
- FDA Registered & cGMP Compliant
- ISO 17025 Accredited Laboratory
- Advanced Particulate ID Workflow
Accelerating Medicine Your Journey Tomorrow Together
Precision Analytical Testing for Early-Phase Pharmaceuticals & Medical Devices
At Gateway Analytical, 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.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
Gateway Analytical: Your Partner in Precision
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.
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.
Our Specialized Services
Pharmaceutical Analysis
Comprehensive testing for drug formulation, compound purity, stability verification, and regulatory compliance. Ensuring quality and efficacy in every analytical batch.
Forensic Testing
Materials Characterization
Deep chemical composition analysis, microstructural diagnostics, and mechanical testing to comprehend physical property behaviors under varying stress profiles.
Ready to solve your most complex analytical challenges?
Partner with our elite team of scientists and modern laboratory facilities to unlock high-precision insights, robust technical validation, and scale your product development with ultimate clarity.
Laboratory Divisions & Navigation
Chromatography
Microscopy Center
Genomics & Bio
Material Analysis
Analytical Intelligence Hub
Advancements in High-Resolution Mass Spectrometry
Implementing AI in Automated Sample Assay Workflows
