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.
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.
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.
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
Next-Generation Sequencing for Precision Medicine
Advanced Analysis Solutions
Particulate Analysis
Precise isolation, identification, and sizing of foreign microscopic particulate matter down to sub-micron scales.
Material Characterization
Comprehensive chemical, structural, and thermal assessment of advanced polymers, metals, and composite structures.
Pharmaceutical Testing
Fully compliant assays under strict cGMP standards, examining drug purity, stability, and excipient compatibility.
Forensic Analysis
Rigorous investigation of trace material evidence, sample cross-contamination, and root-cause product failures.
Quality Control
Routine surveillance and end-product release analytics ensuring compliance with custom target parameters.
Method Development
Custom verification, rapid optimization, and formal validation of sophisticated chromatography procedures.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
Analysis Solutions
Particulate Risk Investigation and Root-Cause Intelligence
Precision sizing, distribution counting, and identification of micro-particles to guarantee ultimate product purity and strict regulatory compliance.
Container Closure and Product-Package Integrity
Detailed molecular, structural, and chemical analysis of complex polymers, crystals, and advanced pharmaceutical compound formulations.
Particle Characterization Beyond Compendial Counts
Comprehensive assay validation, dissolution testing, and purity analyses performed under strict adherence to USP, EP, and FDA guidelines.
Parenteral Packaging Functional Suitability
Trace evidence profiling, chemical fingerprinting, and structural failure analysis supported by advanced modern spectroscopy equipment.
Quality Control
Standardized batch-to-batch consistency testing, defect profiling, and rigorous validation protocols to secure global manufacturing quality.
Method Development
Customized diagnostic assay design, phase transfer validation, and robust optimization of critical, state-of-the-art laboratory workflows.
ANALYSIS SOLUTIONS
- Liquid Particle Sizing
- Airborne Monitoring
- Nanoparticle Tracking
- Polymer Evaluation
- Surface Area Analysis
- Thermal Conductivity
- Dissolution Profiling
- Stability Testing
- Extractables & Leachables
- Trace Evidence Analysis
- Toxicology Screen
- Document Verification
- GMP / GLP Compliance
- OOS Investigation
- Regulatory Audit Prep
- HPLC / GC Validation
- Spectroscopy Setup
- Custom Protocol Design
- Regulatory Filings
- Lab Setup Advisory
- Technical Seminars
Scientific Clarity for Complex Problems
Establishing GTW’s strategic market identity through Lifecycle Quality Risk Control. Precision analytical testing tailored for pharma innovation.
- cGMP Compliant & FDA Registered Laboratory Facilities
- Specialized in Particulate Identification & Material Characterization
Specialized Testing & Analysis Solutions
Particulate Risk Investigation
Visible particle and root-cause intelligence. Uncover origin patterns with high-fidelity analytics and forensic chemical profiling.
Container Closure & Integrity
CCIT, vacuum decay, and HVLD methodologies. Reliable sterile barrier verification for vials, syringes, and custom cartridges.
Particle Characterization
Beyond standard compendial counts. Leverage Flow Imaging Microscopy (FIM) and custom subvisible analysis for deep characterization.
Parenteral Suitability
Comprehensive testing for USP <382> and parenteral delivery systems. Certify device-container harmony and dynamic performance profiles.
Lifecycle Quality Risk Control
Connecting physical integrity profiling with real-time risk mitigation methodologies across drug development lifecycles.
Target Markets & Applications
Connecting advanced therapeutic development with robust, compliant, and precision-driven analytical workflows.
Biologics & Therapeutics
Optimizing molecular stability and structure throughout the development pipeline.
- FIM (Flow Imaging Microscopy)
- Subvisible characterization
- Lifecycle & stability understanding
Sterile Injectables
Ensuring container integrity and sterility validation for high-risk injectables.
- Visible particulate investigations
- Container Closure Integrity Testing (CCIT)
- USP compendial compliance
Advanced Therapies
Specialized characterization protocols engineered for novel cell & gene therapies.
- Small-batch investigations
- Cryogenic concerns & logistics
- Ultra-low temperature validation
Solving Your Most Critical Analysis Challenges
Select your core analytical or regulatory obstacle below to explore our targeted scientific workflows and expert consultancy services.
I found visible particles
Isolate, characterize, and source-trace visible particulate contamination to resolve batch deviations and maintain sterile safety standards.
I have a product complaint
Rapid physical-chemical forensics and root-cause analysis investigations to thoroughly address and resolve end-user market complaints.
I need to identify unknown material
Leverage advanced FTIR, Raman, SEM-EDS, and MS fingerprinting techniques to conclusively identify material composition.
I need to select a CCIT method
Select, validate, and execute deterministic leak detection methods optimized specifically for your package’s geometry.
I need to understand subvisible particles
Quantify and analyze subvisible particles (2-100 μm) utilizing USP <787>, <788>, and optical imaging modalities.
I need to demonstrate USP suitability
Verify fitness-for-use criteria under the new USP <382> requirements for syringe, cartridge, and vial containment systems.
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.