What Ceutical Labs does

Ceutical Labs is a privately held U.S. laboratory testing and regulatory consulting firm headquartered at 1500 Lakeside Parkway, Suite 100A, Flower Mound, Texas. Founded in 2008 by Susanne Armand and Courtland Imel, the company serves pharmaceutical, nutraceutical, medical device, cosmetic, veterinary, and dietary supplement manufacturers, with client engagement spanning small 'Mom and Pop' operations through Fortune 100 enterprises.

The company's core offerings consist of two primary lines: (1) Laboratory Testing Services covering in-process, finished product, raw material, stability, post-sterilization (including ethylene oxide residual), product degradation, and product aging testing, supported by microbiology, physical (ASTM, USP, ISO), and chemistry testing capabilities using HPLC, GC, and AA methods; and (2) the Ceutical Labs Certification Program, a supplier/manufacturer consortium model that issues a Ceutical Labs Certified seal under shared quality systems. Supporting service modules include regulatory affairs (IND, NDA, ANDA, 510K, PMA, DMF submissions, FDA warning letter and consent decree response, ISO13485/ISO9000), quality systems management, outsource manufacturing, and electronic FDA submissions. The Analytical Testing Division (acquired from CPM Laboratory) provides a 2-3 day testing turnaround versus an industry average of 5-10 days.

Ceutical Labs operates a professional services revenue model with quote-based pricing, delivered through direct enterprise sales with no disclosed public pricing tiers. The firm employs 101-250 people, is founder-owned with no disclosed institutional investors or funding rounds, and markets through blog content and organic social (LinkedIn, Facebook, Twitter) rather than paid acquisition.

Name

Ceutical Labs

Legal name

Ceutical Laboratories, Inc.

Website

https://ceuticallabs.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

101–250 employees

Short description

Ceutical Labs is a Texas-based private laboratory testing and regulatory consulting firm serving pharmaceutical, nutraceutical, medical device, cosmetic, veterinary, and dietary supplement manufacturers through analytical testing, the Ceutical Labs Certification Program, and end-to-end regulatory and business development services.

Ownership category

akta.pro rank

Product category

Pharmaceutical and Medical Device Testing Services

NAICS

Testing Laboratories and Services (54138), Medical Laboratories (621511), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Testing Laboratories (8734), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Analytical Development & QC Testing (Release/Stability/Potency) (HLAGAGAF)

akta.pro secondary industries

Release Testing & Batch Certification (QC) (HLAGADAC), Food, Feed & Nutraceutical Analytical Testing (HLAGADAN), Quality Management & Regulatory Compliance (CLIA/CAP/ISO) for Labs (HLACAMAH)

Keywords

• Pharmaceutical testing services
• Medical device testing
• Regulatory affairs consulting
• CGMP compliance services
• Analytical laboratory testing

Headquarters

HQ city

Bedford

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. Laboratory Testing Services: Comprehensive analytical testing services including in-process, finished product, raw material, stability, sterilization, and degradation testing for pharmaceutical, nutraceutical, medical device, API, and NDI products.
2. Ceutical Labs Certification Program: Supplier and manufacturer certification program providing quality systems validation, quality assurance, document control, regulatory affairs, training, project management, and outsource manufacturing services.
3. Regulatory and Business Development Consulting: End-to-end business development services from concept to sales, marketing, and distribution including FDA approvals, clinical trials, manufacturing, quality management, and regulatory submissions.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Ceutical Labs is a laboratory testing and regulatory consulting firm serving the pharmaceutical, medical device, nutraceutical, cosmetic, veterinary, and dietary supplement industries. The company provides comprehensive analytical testing services (in-process, finished product, raw material, stability, post-sterilization, ethylene oxide, microbiology, physical, and chemistry testing) along with regulatory affairs (IND, NDA, ANDA, 510K, PMA, DMF submissions), quality systems management, product development, outsource manufacturing, and the Ceutical Labs Certification Program connecting suppliers, manufacturers, and distributors.

Product overview

Ceutical Labs is a laboratory testing and certification company serving pharmaceutical, nutraceutical, medical device, cosmetic, and dietary supplement industries. The core offerings consist of Lab Testing Services (covering Pharmaceutical, Nutraceutical, Medical Device, API, NDI, and Post Sterilization Testing) and the Ceutical Labs Certification Program that provides supplier/manufacturer quality certification. The company operates the Analytical Testing Division (formerly CPM Laboratory) for rapid 2-3 day turnaround testing. Supporting service modules include Regulatory Affairs (IND, NDA, ANDA, 510K, PMA, DMF submissions), Quality Systems Management, Product Development, Microbiology Testing, Physical Testing, Chemistry Testing, Business Development, and Electronic Submissions to FDA. Founded by Susanne Armand (President) and Courtland Imel (Founder) with over 16-20 years of industry experience.

Differentiator

Problem solved

Functional benefit

Products and services

• Lab Testing Services

Quantifiable outcome

• 2-3 day turnaround vs industry average of 5-10 days
• +3 more outcomes

Segments7 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature11 records

Scale indicators4 records

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• Eurofins Scientific: Global leader in bioanalytical and pharmaceutical testing services offering release, stability, microbiology, and physical testing across pharma, medical device, and nutraceutical verticals. Directly comparable to Ceutical Labs in service offering but vastly larger in scale, geographic reach, and instrument breadth, competing for the same SMB and mid-market clients.
• Charles River Laboratories: Major CRO and laboratory services provider with strong pharmaceutical and medical device testing franchises, including microbiology, chemistry, and release testing. Competes with Ceutical Labs across pharma/medical device testing but with much broader scientific depth and global footprint.
• SGS: Global testing, inspection, and certification company with extensive life sciences capabilities including pharmaceutical, medical device, and nutraceutical analytical testing. Comparable in service mix to Ceutical Labs but operates at a much larger scale across multiple geographies.
• Intertek: Total quality assurance provider offering analytical testing, certification, and regulatory support across pharmaceutical, medical device, food, and consumer products. Highly comparable service portfolio to Ceutical Labs with global scale advantage.
• WuXi AppTec: Global CRO/CDMO offering comprehensive pharmaceutical testing, analytical development, and regulatory services. Competes with Ceutical Labs for pharma testing and regulatory work but operates at significantly greater scale with integrated development capabilities.

Direct peers

• Pace Analytical: US-focused network of analytical testing laboratories providing chemistry, microbiology, and physical testing services to pharmaceutical, medical device, and consumer products manufacturers. Closest US mid-market comparable to Ceutical Labs in terms of service mix, client segment, and operating model.
• Nelson Laboratories (Sotera Health): Specialized medical device and pharmaceutical testing laboratory offering sterilization validation (including EO residual testing), package testing, and microbiological testing. Highly comparable to Ceutical Labs' medical device testing capabilities including EO testing, aging studies, and post-sterilization work.
• Microbac Laboratories: Mid-sized US analytical testing network providing chemistry, microbiology, and physical testing to pharmaceutical, medical device, food, and environmental clients. Closely comparable to Ceutical Labs in client segment (SMB manufacturers) and service breadth across multiple regulated verticals.
• Pacific BioLabs: Independent contract laboratory providing analytical chemistry, microbiology, and biocompatibility testing for pharmaceutical and medical device manufacturers. Directly comparable niche CRO serving similar SMB and mid-market clients with similar service mix.
• EMSL Analytical: US analytical testing laboratory providing chemistry, microbiology, and materials testing to pharmaceutical, nutraceutical, and consumer products manufacturers. Comparable mid-sized competitor with multi-vertical testing focus similar to Ceutical Labs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/ceuticallabs
• Facebookfacebook.com/ceuticallabs
• LinkedInlinkedin.com/company/ceutical-laboratories-inc-

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries1 record

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 Ceutical Labs