What CS Analytical does

CS Analytical is a privately held, cGMP-compliant and FDA-registered contract laboratory based in Clifton, New Jersey, exclusively dedicated to container closure integrity (CCI) and packaging qualification testing for the pharmaceutical, biotechnology, and medical device industries. The company is described in its own materials as the world's only contract laboratory exclusively designed and dedicated to package and container testing, differentiating it from general analytical CROs. Its technical platform is organized around four deterministic USP <1207>-aligned leak detection technologies — helium leak detection via mass spectrometry (Leak Detection Associates SIMS 1915+, capable of leak rates down to E-11 mbar.l/s), high-voltage leak detection (2–3 micron defect sensitivity), vacuum decay, and laser-based headspace analysis — supplemented by physicochemical testing (USP 1663/1664 extractables and leachables, USP <661.1>/<661.2> plastics, USP <660> glass, USP <381> elastomers, USP <232>/<233>/ICH Q3D elemental impurities), functional performance testing (USP <671> permeation, USP <670> desiccant, USP <382> elastomer functionality, Mocon gas transmission), and complementary services including cold/ultracold CCI down to -80°C, ASTM D4169-23/ISTA distribution testing, accelerated aging, and USP <87> biological reactivity. The laboratory holds USDA BSL-2 certification for vaccine/biologic testing and maintains GDPR compliance.

The company's revenue model is professional services-based, with project-specific, quote-based pricing for CCI method development and validation programs that typically run 10–12 weeks, followed by ongoing routine testing under multi-year contracts. Go-to-market is exclusively direct enterprise field sales targeting pharma, biotech, and medical device sponsors, supplemented by thought-leadership content marketing (educational blogs, webinars on USP chapter changes including sold-out USP 661.1/661.2 sessions), industry conference presence at INTERPHEX and Contract Pharma events, and video/lab tour content. Lead scientific personnel include CSO Brandon Zurawlow and Director of Scientific Affairs Jennifer Roark (30+ years cGMP analytical chemistry experience), with Brian Mulhall serving as CEO. As of mid-2026, the company is in active expansion mode, with announced plans to double its Clifton laboratory footprint to support three newly launched service lines (Raw Material Analytical services, RM Analytical sub-brand, and Micro/Biological Testing), alongside the May 2025 operationalization of expanded ASTM D4169-23/ISTA distribution testing capabilities built around a custom Lansmont vibration platform and Abbess Temperature and Altitude chamber.

Name

CS Analytical

Legal name

CS Analytical

Website

https://csanalytical.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

CS Analytical is a private, cGMP-compliant and FDA-registered contract laboratory in Clifton, New Jersey, exclusively dedicated to USP <1207> container closure integrity and pharmaceutical packaging qualification testing for pharma, biotech, and medical device companies worldwide.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Testing Services

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Extractables & Leachables / Container-Closure Testing (HLAGADAI)

akta.pro secondary industries

Release Testing & Batch Certification (QC) (HLAGADAC), Elemental Impurities & Trace Metals (ICP-MS) (HLAGADAJ)

Keywords

• Container closure integrity testing
• Pharmaceutical package testing
• USP compendial testing
• Extractables leachables testing
• Contract laboratory services

Headquarters

HQ city

Clifton

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Laboratory Testing Services: CS Analytical generates revenue through providing cGMP-compliant, FDA-registered contract testing services for pharmaceutical, biotechnology, and medical device companies. Services include CCI method development, validation, and routine analysis; USP/EP/JP physicochemical testing; functional performance testing; and comprehensive complementary services. Revenue is project-based with testing programs typically taking 10-12 weeks for development and validation, with ongoing routine testing for clients.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

CS Analytical operates as a cGMP, FDA-registered contract laboratory exclusively dedicated to pharmaceutical, biotechnology, and medical device container and package testing. The company provides Container Closure Integrity Testing (CCIT) using multiple USP 1207-compliant technologies (helium leak detection/mass spectrometry, high voltage leak detection, vacuum decay, and laser-based headspace analysis), physicochemical testing per USP/EP/JP compendial methods, functional performance testing, and extractables/leachables testing. Services are delivered through method development, validation, and routine analysis programs.

Product overview

CS Analytical is a cGMP and FDA-registered contract laboratory exclusively dedicated to pharmaceutical packaging and container testing for the pharmaceutical, biotechnology, and medical device industries. The company's service offering is organized around four core pillars: Container Closure Integrity Testing (CCIT), Functional Performance Testing, Physicochemical Testing, and Comprehensive and Complementary (C&C) Solutions, supported by Advisory Services. The CCIT portfolio includes four primary detection technologies (High Voltage Leak Detection, Laser-Based Headspace Analysis, Vacuum Decay, and Helium Leak Testing) applied to custom solutions and IV bag systems. Functional Performance Testing covers permeation, desiccant capacity, elastomer functionality, and gas transmission. Physicochemical Testing encompasses extractables and leachables (USP 1663/1664), plastic materials and systems (USP 661.1/661.2), glass (USP 660), elastomers (USP 381), and elemental impurities (USP 232/233/ICH Q3D). In early 2026, the company expanded its portfolio through RM Analytical (Raw Material and Finished Product Testing) and micro/biological testing services (USP 87, USP 788). All services support compliance with USP, EP, JP, FDA, and EU regulatory requirements.

Differentiator

Problem solved

Functional benefit

Products and services

• Container Closure Integrity Testing (CCIT) Comprehensive USP 1207-compliant Container Closure Integrity Testing services including method development, validation, and routine analysis for pharmaceutical, biotechnology, and medical device packaging. The service employs four primary detection technologies (Helium Leak Detection/Mass Spectrometry, High Voltage Leak Detection, Vacuum Decay, and Laser-based Headspace Analysis) and covers custom solutions, IV bags, cold and ultracold storage products (down to -80°C), and combination products.
• Functional Performance Testing Testing services evaluating container and package ability to demonstrate suitability for intended function, including protection from light and moisture (USP 671 permeation, USP 670 desiccant adsorption), elastomer functionality (USP 382), ASTM Mocon gas transmission, seal integrity, dose accuracy/deliverable volume, seal strength, and break-loose and glide testing.
• Physicochemical Testing

Quantifiable outcome

• Method development and validation typically takes 10-12 weeks for comprehensive CCI programs
• +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

Feature8 records

Partnerships

One partnership is on record.

• E-2 ConsultingminorOthers · 8 April 2025CS Analytical signed an IT system support agreement with E-2 Consulting for ongoing information technology infrastructure and system support services at the Clifton, New Jersey facility.

Scale indicators4 records

Recent moves8 records

Expansion highlights5 records

Broad incumbents

• SGS: SGS operates a global life-sciences testing network including pharmaceutical and medical device package testing and microbiological services, serving the same pharma/biotech/medical device buyer base as CS Analytical.
• WuXi AppTec: WuXi AppTec is a large global CRO/CDMO providing analytical, testing, and packaging support to pharma and biotech; it competes for outsourced testing budgets alongside CS Analytical, especially among biotech clients.
• Eurofins Scientific: Eurofins is a global testing services conglomerate with pharma packaging, extractables/leachables, and microbiology capabilities across many sites; it competes with CS Analytical as a broad incumbent rather than a dedicated CCIT specialist.
• Intertek: Intertek provides pharmaceutical and medical device testing services including packaging integrity, materials characterization, and regulatory support, with a global footprint that contrasts CS Analytical's single-site niche model.
• Charles River Laboratories: Charles River provides laboratory and contract research services including pharmaceutical and medical device testing; it is a broad incumbent that competes for testing RFPs even if not exclusively focused on container closure integrity.

Others

• Stevanato Group: Stevanato Group supplies pharmaceutical glass primary packaging and drug containment solutions and also offers analytical and testing services for container systems, making it a packaging-supplier-side adjacent participant.
• West Pharmaceutical Services: West Pharmaceutical is a primary packaging components manufacturer that also offers analytical services and testing support for elastomer/closure systems, making it an adjacent ecosystem participant and potential competitor for in-house testing decisions.

Emerging players

• Gateway Analytical: Gateway Analytical is a smaller cGMP analytical services lab focused on pharmaceutical materials, particle identification, and packaging-related testing; it is comparable as a niche analytical services peer rather than a full CCIT specialist.

Direct peers

• Nelson Labs: Nelson Labs is a contract testing laboratory for the medical device and pharmaceutical industries, offering package integrity, extractables/leachables, and microbiological testing closely overlapping CS Analytical's CCIT, physicochemical, and USP 87 service lines.
• Toxikon: Toxikon is a contract preclinical and medical device testing laboratory providing extractables/leachables, biocompatibility (USP 87/88), and packaging integrity testing for pharma and medical device clients — a direct functional peer to CS Analytical's physicochemical and biological reactivity services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/csanalytical
• Facebookfacebook.com/CS-Analytical

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 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 CS Analytical