What Gateway Analytical does

Gateway Analytical, founded in 2010 and headquartered in Gibsonia, Pennsylvania, is a cGMP-compliant analytical testing laboratory specializing in chemical and materials analysis for pharmaceutical, biotechnology, and medical device companies. The company operates from a ~17,000 sq ft facility with HEPA-filtered clean rooms and a dedicated cytotoxic-handling area, and holds a dense stack of credentials including FDA registration, DEA controlled-substance licensing, ISO 17025, ISO 9001, ASCLD/LAB-International accreditation, and recognition from Health Canada and EMA. Its service catalog spans the full drug-product lifecycle: Extractables & Leachables testing (USP <661-665>, <1663-1664>), Container Closure Integrity Testing (CCIT) using vacuum decay, laser-based gas headspace analysis, and high voltage leak detection (HVLD), Particulate Analysis (USP <787>/<788>/<789>, EP 2.6.20, JP 6.07), Functional Suitability Testing (USP <382>), Visual Inspection, Glass Delamination Analysis, Accelerated Aging Studies, ICH Stability Storage, and Medical Device Analysis. The company's technical backbone rests on advanced chromatography (Triple Quadrupole LC-MS/MS, GC-MS), spectroscopy (Raman, FTIR), and microscopy (SEM-EDS), combined into a multi-analytical forensic approach. Gateway also holds a patented Raman Chemical Imaging method that delivers chemically specific particle characterization at the pixel level — a differentiator for FDA submissions on orally inhaled and parenteral products. The company was acquired by Aptar in June 2019 and now operates as part of Aptar's pharma services division.

Name

Gateway Analytical

Legal name

Gateway Analytical LLC

Website

https://gatewayanalytical.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

Gateway Analytical is a cGMP-compliant analytical testing laboratory serving pharmaceutical, biotechnology, and medical device companies with particulate analysis, container closure integrity testing, extractables and leachables studies, and patented Raman chemical imaging.

Ownership category

akta.pro rank

Product category

Pharmaceutical Analytical Testing Services

NAICS

Testing Laboratories and Services (54138), Testing Laboratories and Services (541380)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Extractables & Leachables / Container-Closure Testing (HLAGADAI)

akta.pro secondary industries

Release Testing & Batch Certification (QC) (HLAGADAC), Small-Molecule Analytical Development & Method Validation (CMC) (HLAGAHAF)

Keywords

• Analytical testing services
• Pharmaceutical laboratory testing
• Container closure integrity
• Extractables and leachables
• Particulate matter analysis

Headquarters

HQ city

Gibsonia

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Analytical Testing Services: Gateway Analytical generates revenue through providing contract analytical testing services to pharmaceutical, biotechnology, and medical device companies. Services are delivered on a project-by-project basis with pricing based on scope, complexity, and turnaround time requirements. Payment terms are 30 days from invoice date.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Gateway Analytical is a cGMP-compliant analytical testing laboratory that provides chemical and materials analysis services to pharmaceutical, biotechnology, and medical device companies. Its offerings include extractables and leachables testing, container closure integrity testing (CCIT), particulate analysis, advanced chromatography, glass delamination analysis, and functional suitability testing for packaging and drug delivery systems. The company also provides method development, method verification, and regulatory consulting support for BLA/NDA submissions.

Product overview

Gateway Analytical offers a comprehensive suite of analytical testing services organized as a platform of interconnected laboratory solutions. The core offerings include Extractables & Leachables Testing (covering USP <661-665> and <1663-1664> for pharma applications), Container Closure Integrity Testing (CCIT with vacuum decay, laser-based headspace analysis, and HVLD technologies), Particulate Analysis (USP 787/788/789 compliance, subvisible and visible particle counting), and Functional Testing (USP 382 compliance for elastomeric components). Additional services include Medical Device Analysis, Early-Phase Development, Visual Inspection, Glass Delamination Analysis, Accelerated Aging Studies, ICH Stability Storage, and Quality Control/Release Testing. The company also offers specialized Method Verification Consultations and ParticleID services for advanced particle identification. All services are delivered through FDA-registered, cGMP-compliant, DEA-licensed facilities with ISO 17025 and ISO 9001 accreditation.

Differentiator

Problem solved

Functional benefit

Products and services

• Extractables & Leachables Testing Studies aimed at identifying potentially harmful chemical compounds that could migrate from manufacturing components and final containers into pharmaceutical products to ensure safety and efficacy, primarily for pharmaceutical manufacturers.
• Advanced Chromatography Comprehensive chromatography services including Triple Quadrupole LC-MS/MS, PAH Detection via GC-MS, early biologics support, nitrosamine method development, PFAS testing, small molecule impurity and assay development, and custom method development and validation for pharmaceutical and biotech clients.
• Container Closure Integrity Testing (CCIT) Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles, including vacuum decay, laser-based gas headspace analysis, and HVLD methods for pharmaceutical packaging.
• Particulate Analysis Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices, including USP 787/788/789 and EP 2.6.20 / JP 6.07 release testing.
• Functional Suitability Testing Testing services for pharmaceutical packaging including USP 382 compliance, break loose glide force, needle and spike access functionality, packaging integrity tests, plunger functional suitability, residual seal force, and tip cap effectiveness.
• Medical Device Analysis 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, targeted at medical device manufacturers.
• Early-Phase Development Support Comprehensive analytical packages designed to navigate clinical and regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.
• Visual Inspection Support Inspection services for injectable and parenteral medicines ensuring products are free from harmful particulate matter per USP <790> requirements.
• Glass Delamination Analysis Detection and mitigation services for glass delamination in pharmaceutical packaging using advanced techniques such as SEM and EDS to identify glass flakes down to the micron level.
• Accelerated Aging Studies Studies to assess product stability and shelf life under accelerated conditions for pharmaceutical packaging validation.
• ICH Stability Storage & Sample Storage Climate-controlled storage services and ICH stability studies for pharmaceutical products under various temperature and humidity conditions.
• USP Method Verification Consultations Specialized consulting services for USP <787>, <788>, and <789> method verification to ensure analytical procedures are suitable for specific drug formulations and regulatory submissions.
• ParticleID Particle identification services using advanced analytical techniques for foreign particulate matter characterization and source determination, leveraging Raman chemical imaging and complementary spectroscopy/microscopy methods.

Quantifiable outcome

• Regulatory submissions supported through inspection-ready documentation and technical documentation providing regulatory confidence during BLA/NDA submissions
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• DDL, Inc.coreStrategic or Co-development Partner · 18 September 2017DDL and Gateway Analytical entered into a joint agreement to offer complementary testing services to pharmaceutical, biotech, and medical device industries. DDL provides mechanical testing, ASTM testing method services, and stability sampling/storage. Gateway Analytical provides foreign particulate characterization, materials characterization, and extractable/leachable studies. The partnership enables customers to access a more comprehensive range of solutions and expertise.
• Chemic Laboratories Inc.coreStrategic or Co-development Partner · 18 November 2015Gateway Analytical and Chemic Laboratories established a formal joint cooperation agreement to collaborate on pharmaceutical and biopharmaceutical client interests, primarily in extractables, leachables, visible and sub-visible particulate analysis supporting Single-Use Systems (SUS). The companies leverage collective expertise in chromatographic, spectroscopic, and microscopic analytics to provide extractable and particulate matter data assessing material compatibility and suitability for biopharma use.

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• SGS: SGS is a leading global testing, inspection, and certification company with a substantial life sciences analytical services practice covering pharma, biotech, and medical devices. It competes with Gateway on pharmaceutical analytical work while also serving many non-pharma sectors.
• Catalent: Catalent is a major pharmaceutical CDMO with extensive analytical services including release, stability, and method development for biologics and small molecules. It competes with Gateway for pharmaceutical analytical testing programs at a much larger scale and broader service portfolio.
• Charles River Laboratories: Charles River Laboratories is a major CRO offering pharmaceutical analytical services (E&L, container closure, particulates, stability) alongside its broader preclinical and manufacturing services. Its end-to-end biopharma offering overlaps with Gateway's testing portfolio for similar pharma customers.
• WuXi AppTec: WuXi AppTec provides a broad range of pharmaceutical analytical, CMC, and testing services globally, including E&L and release testing for biologics and small molecules. It serves many of the same pharma/biotech customers as Gateway but at significantly larger scale.
• Intertek: Intertek is a global quality and testing services group serving pharmaceutical, medical device, and chemical clients with analytical, packaging, and E&L capabilities. It overlaps directly with Gateway's pharmaceutical testing portfolio but competes across many adjacent industries as well.
• Eurofins Scientific: Eurofins is one of the world's largest testing services groups with deep pharmaceutical analytical offerings including E&L, particulate, and container closure testing. It competes with Gateway on virtually every service line but operates at vastly greater scale, geographic reach, and bundled service breadth.

Direct peers

• Alcami Corporation: Alcami is a pharmaceutical contract development and analytical services organization offering release and stability testing, method development, and characterization services. It overlaps directly with Gateway's pharmaceutical testing offering for similar pharma customers.
• Toxikon: Toxikon is a contract analytical and preclinical testing laboratory specializing in pharmaceutical, medical device, and packaging testing, including E&L and biocompatibility work. It is a direct niche competitor to Gateway in pharmaceutical analytical testing with comparable scale and service mix.
• Nelson Laboratories: Nelson Laboratories is a contract testing laboratory specializing in medical device and pharmaceutical microbiology, biocompatibility, and analytical testing including E&L and particulate work. It is a directly comparable specialty testing peer in the same pharma/medical device analytical niche.
• Smithers: Smithers provides specialist testing, analytical, and consulting services to pharmaceutical, medical device, and packaging clients, including extractables/leachables and particulate testing. It is a comparable specialty testing peer for Gateway Analytical.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/gatewaytweets

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Gateway Analytical