Gateway Analytical

Analytical testing service to identify foreign contaminants present in drug products, determine their composition, assess potential impact on safety and quality, and determine their ultimate source.

Analytical testing service to evaluate visible particulates in injections according to USP 790 standards.

Expert analytical testing services and program development support designed to help pharmaceutical companies adhere to USP 790 and 1790 requirements for visible defect and foreign particulate matter inspection in injectable and parenteral products.

The RA802 Pharmaceutical Analyser is a dedicated high-speed Raman system designed for pharmaceutical analysis, generating comprehensive chemical images of sample surfaces quickly.

Bioequivalence studies utilizing chemical imaging technologies like Raman-based systems and elemental analysis systems to support generic drug developers with FDA approval.

An analysis service providing a detailed accounting of foreign particulate matter present in pharmaceutical products, cell-based therapy products, and medical devices using automated high-throughput techniques.

The Single Particle Explorer quickly determines the size, shape, count and chemical composition of large populations of particles down to 2 microns in size using imaging and spectroscopy.

Comprehensive functional testing services for pharmaceutical applications, focusing on materials used in drug delivery devices and packaging systems such as syringes, vials, and cartridges.

Source determination analysis helps detect the origins of contaminants in drug products, identifying where foreign material came from, when it entered the manufacturing process, and how to prevent recurrence.

Comprehensive extractables and leachables (E&L) analytical testing services for pharmaceutical and medical device companies to ensure product safety, quality, and regulatory compliance.

An advanced container closure integrity testing solution that uses electrical conductivity and capacitance to perform a non-destructive and deterministic test for detecting leaks in packages containing liquid or semi-liquid products.

Release and stability testing using USP <787>, <788>, and <789> Methods I & II, including method development and verification.

Advanced analytical testing and characterization services for particulate matter in pharmaceutical products to ensure quality, regulatory compliance, and patient safety.

A particulate identification database solution and software that compiles, stores, searches, and mines analytical data for foreign particulate and materials investigations.

In-house method development and validation service using triple quadrupole LC-MS/MS for trace-level leachables, genotoxic impurities, and targeted contaminants.

Foreign particulate matter investigations to identify types of particles present, assess potential patient impact, trace origins of unwanted particulates, and ensure pharmaceutical product integrity.

Overview brochure detailing analytical services for Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs).

Multi-analytical approach to characterize and identify unknown particulates or materials greater than 100 micrometers with source determination and root cause analysis.

Standardized Extractables and Leachables (E&L) testing protocol for single-use bioprocess containers based on BioPhorum Operations Group guidelines.

Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

Measures the sealing force of container closures, supporting the dedication to maintaining the highest levels of product safety and efficacy.

Brief overview brochure detailing a multi-analytical approach to see medical products from development stages through medical application.

Lot release particulate testing service covering USP 787, 788, and 789 compendial standards.

Specialized rinse study testing to evaluate cleanliness and particulate burden of primary packaging, closures, and single-use manufacturing components.

Raman Chemical Imaging services for the analysis of medical devices to determine the distribution of API in polymers, directly relating to stent design and product testing.

Foreign particulate identification (>100 µm) utilizing a multi-analytical approach to characterize and identify unknown particulates or materials.

Systematic comparison approach and customer example for identifying potential sources of contaminants in processes, raw materials, and production steps.

Specialized method verification consultation services designed to help pharmaceutical teams navigate the regulatory requirements of USP <787>, <788>, and <789> for subvisible particulate matter testing.

Comprehensive packages designed to navigate clinical and regulatory complexities of parenteral product-package and container-closure development.

A non-destructive, quantitative leak test method that detects leakage in non-porous, rigid, or flexible packages in the package headspace gas region and below the product-fill level.

Comprehensive GC-MS and LC-MS screening workflows for volatile and non-volatile extractables designed for in-depth characterization, identification, and structural elucidation of unknowns.

Tailored analytical solution for developing and validating custom methods across advanced instrumentation including triple quadrupole LC-MS/MS, QTOF-MS, and GC-MS systems adhering to ICH Q2(R2) guidelines.

A benchtop headspace oxygen analyzer that measures oxygen concentration in sealed parenteral containers using laser-based gas headspace analysis technology.

Specialized particulate testing and inspection services for complex or difficult-to-inspect parenteral products.

Simulates shipping conditions to test container closure integrity, ensuring the package's comprehensive approach to product protection throughout distribution.

Brief overview brochure detailing analytical testing laboratory solutions for foreign particulate characterization and materials analysis needs.

A benchtop headspace carbon dioxide analyzer that measures CO2 concentration in sealed parenteral containers for container closure integrity testing and process monitoring.

Proactive and reactive raw materials analysis services utilizing microscopy, FTIR, Raman, and SEM-EDS to identify contaminants and impurities, optimize manufacturing processes, and ensure quality standards.

Provides comprehensive stability storage conditions to evaluate container and product interaction over time.

Offers the creation of a cloud-based particle library, expanding capabilities in identifying and cataloging particulate matter for enhanced inspection accuracy.

Failure analysis services for medical devices using standard analytical testing methods such as optical microscopy, SEM/EDS, FTIR, and Raman spectroscopy.

Wear debris testing services utilizing automated scanning electron microscopy to determine size, morphology, and chemistry of inorganic and organic wear debris generated during lifecycle testing.

Root cause analysis examines the nature of failures within your product and determines potential causes of product issues at the sample level for a variety of failures.

Vacuum decay leak testing systems utilizing single or dual vacuum transducer technology for absolute and differential vacuum monitoring.

Partnership program with Next Breath providing drug developers with analytical and product development support from R&D through submission and batch release.

Specialized sample preparation and handling service ensuring samples are properly logged, stored, and prepared according to strict protocols to minimize experimental errors.

Advanced R&D-stage LC-MS/MS workflows purpose-built to meet FDA, EMA, and ICH M7 guidelines for genotoxic impurity analysis and regulatory filings.

Standard sample submission form to initiate analytical testing services with the laboratory.

Custom impurity profiling and potency assay development using LC-MS/MS, GC-MS, and high-res QTOF-MS to support regulatory compliance and product safety.

Provides comprehensive characterization of reference materials, facilitating accurate and reliable visual inspection benchmarks.

Assesses elastomeric parts in parenteral packaging against ISO standards, aligning with the commitment to quality and safety.

A compliant and customizable database solution to help organize analytical results and track progress.

Provides comprehensive strategy formulation and guidance for navigating the regulatory approval process efficiently.

Offers expert support in preparing and reviewing regulatory documentation, ensuring submissions are complete, compliant, and persuasive.