FDA Laboratory LLC

What FDA Laboratory LLC does

FDA Laboratory LLC is an internationally accredited analytical testing laboratory headquartered in Nor Gyugh (Akunk community), Kotayk Province, Armenia, approximately 15 km from Yerevan. Founded in 2012 and operating with approximately 10 employees, it integrates four specialized laboratories under one roof — including drug quality control, food and beverage testing, a Bioequivalence Studies Laboratory, and a tobacco and tobacco substitute products testing department — under Good Laboratory Practice (GLP) and ISO/IEC 17025:2017 compliance. The laboratory was the first in Armenia to obtain international accreditation from the ANSI National Accreditation Board (ANAB) and is designated by the Armenian Ministry of Economy as a Conformity Assessment Body authorized to issue State Registration Certificates (СГР) for the Eurasian Economic Union (EAEU) market.

The company's service catalog spans drug quality control per USP/BP/EP/JP pharmacopoeial methods, GLP-compliant bioequivalence studies using UPLC-MS/MS instrumentation (Waters Xevo TQ-S micro ACQUITY H-Class), food, alcoholic beverage (with VI-1 certificate issuance for EU wine exports), cosmetic, water, fertilizer, and dietary supplement testing. It is the only laboratory in Armenia and the broader region performing tobacco substitute product testing — a capability accredited by the Uzbekistan Accreditation Center under ISO/IEC 17025:2019 and registered in Uzbekistan's National Register. The firm issues test reports accepted by regulatory authorities in the USA, EU, EAEU, China, Japan, and Uzbekistan.

FDA Laboratory operates as a B2B enterprise services provider on a per-test or per-project pay-as-you-go basis, distributing services directly through its Nor Gyugh facility and supported by US contact numbers (New York, Boston, Los Angeles, Austin). Its go-to-market combines international conference participation, government engagement, and targeted B2B working visits — notably an April 2024 Kazakhstan trip that produced cooperation agreements with Philip Morris Kazakhstan, British American Tobacco, and JTI Kazakhstan. The customer base is diversified across pharmaceutical companies, food and beverage producers, cosmetic manufacturers, government bodies (Armenian Ministry of Economy), and contract research organizations, with documented partnerships extending to Certification and Quality LLC for bundled EAC conformity assessment services.

Name

FDA Laboratory LLC

Legal name

«ЭФ-ДИ-ЭЙ Лаборатория» LLC

Website

https://fdalab.am

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

FDA Laboratory LLC is an Armenia-based, internationally accredited analytical testing laboratory operating four specialized labs under one roof. It serves pharmaceutical, food, tobacco, cosmetic, and CRO clients with GLP/ISO 17025-compliant testing recognized across EAEU, EU, USA, China, and Japan.

Ownership category

akta.pro rank

Product category

Accredited Laboratory Testing and Conformity Assessment Services

NAICS

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

SIC

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

akta.pro primary industry

Clinical Research & Trial Central Laboratories (HLAFAMAL)

akta.pro secondary industries

Release Testing & Batch Certification (QC) (HLAGADAC), Food Testing Laboratories (Microbiological, Chemical, Allergen) (AFALAAAA), Laboratory Testing & Analytical Services (in-house/contract labs; microbiology, metals, organics) (EUANAJAB), Laboratory Quality Systems, Accreditation & Proficiency Testing Programs (HLAJAIAM)

Keywords

• Accredited laboratory testing
• Pharmaceutical quality control
• Bioequivalence studies
• Food safety testing
• Conformity assessment services

Headquarters

HQ city

Nor Gyugh (New Village)

HQ country

Armenia

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Laboratory Testing Services: FDA Laboratory LLC charges for laboratory testing services across a wide range of product categories including food products, pharmaceutical products, alcoholic beverages, tobacco products, cosmetics, fertilizers, and water. Revenue is generated on a per-test or per-project basis depending on the scope of testing required. The laboratory also charges for method development and validation services, training programs, and state registration services.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

FDA Laboratory LLC operates an internationally accredited laboratory complex in Kotayk Province, Armenia, providing comprehensive analytical testing services for food products, pharmaceuticals, alcoholic beverages, cosmetics, tobacco products, water, and fertilizers. The laboratory is designated as a Conformity Assessment Body by the Ministry of Economy of Armenia, issues State Registration Certificates and VI-1 export certificates, and conducts GLP-compliant bioequivalence studies for generic drug registration under EMA, USFDA, and EAEU regulatory frameworks.

Product overview

FDA Laboratory LLC operates as an internationally accredited laboratory complex integrating four specialized laboratories under one roof. The core offerings include comprehensive laboratory testing services covering food products, pharmaceutical products, alcoholic beverages, cosmetics, tobacco products, water, fertilizers, and biological samples. The laboratory provides state registration services, method development and validation, and export/import testing services. The facility operates in compliance with ISO/IEC 17025:2017 and GLP principles, offering testing recognized internationally for product certification and regulatory compliance across EAEU, EU, USA, China, and Japan markets.

Differentiator

Problem solved

Functional benefit

Products and services

• Laboratory Testing Services Comprehensive laboratory testing services covering food products, pharmaceutical products, alcoholic beverages, cosmetics, tobacco products, water, and agricultural products, conducted in accordance with ISO/IEC 17025:2017 and GLP principles for manufacturers, importers, exporters, and government bodies.
• Drug Quality Control Laboratory testing of pharmaceutical raw materials and dosage forms (tablets, capsules, injections, ointments) using USP, BP, EP, and JP pharmacopoeial methods for pharmaceutical manufacturers requiring regulatory compliance documentation.
• Bioequivalence Studies GLP-compliant bioanalytical testing of biological samples within bioequivalence studies, including analytical method development, validation, pharmacokinetic analysis, BCS-based biowaiver studies, and sample storage for generic medicinal product registration per EMA, USFDA, and EAEU guidelines.
• Food Testing Laboratory testing of meat, dairy, fish, fruits, vegetables, honey, preserved foods, confectionery, grains, oils, spices, ready-to-eat foods, tea, and coffee for food manufacturers requiring safety and quality certification per EAEU and international standards.
• Water Testing Testing of potable water, mineral water, bottled water, water for infants, and wastewater/irrigation water for physicochemical and microbiological parameters per applicable technical regulations.
• Alcoholic Beverages Testing Laboratory testing of wine, beer, brandy, and vodka including VI-1 certificate issuance required for entry of wine into the European Union market.
• Tobacco Products Testing Testing of tobacco and tobacco substitute products including cigarettes, heated tobacco, and electronic cigarettes for nicotine, tar, carbon monoxide, glycerin, propylene glycol, and water content. The only laboratory in Armenia and the region offering this testing, accredited by Uzbekistan Accreditation Center.
• Cosmetic Products Testing Safety and quality testing of cosmetic products in accordance with CU TR 009/2011 for state registration and market circulation in EAEU member states.
• State Registration Service (СГР) State registration service for products subject to mandatory registration, issuing State Registration Certificates recognized across EAEU member states and registered in the Unified Register of State Registration Certificates of the Customs Union.
• Method Development and Validation Development of new analytical methods and validation of existing methods for food, pharmaceutical, alcoholic beverages, and raw material categories, including evaluation of accuracy, reproducibility, repeatability, specificity, limits of detection and quantification, and range.
• Export Testing Services Laboratory testing services supporting product exports to USA, EU, China, Japan, and EAEU member states, including compliance with specific regulatory requirements of each destination market and ANAB-accredited test reports for US FDA/USDA.
• Import Testing Services Laboratory testing of imported products in accordance with Armenian and EAEU technical regulations for customs clearance and market entry into the Republic of Armenia and EAEU territory.
• Fertilizer Testing Laboratory testing of fertilizers within the scope of accreditation in accordance with Technical Regulations of the Customs Union for agricultural input suppliers and importers.
• Biologically Active Food Supplements Testing Safety, quality, and composition testing of dietary supplements for EAEU territory registration including export, import, and market circulation.
• Dietary, Sports Nutrition, and Baby Food Testing Laboratory testing for dietary food, sports nutrition products, and baby food in accordance with EAEU technical regulations for state registration and market circulation.

Quantifiable outcome

• First laboratory in Armenia accredited by ANAB per ISO/IEC 17025:2017 — international recognition of work quality
• +2 more outcomes

Named customers4 records

Segments6 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Uzbekistan Accreditation Center (O'zbekiston akkreditatsiya markazi)coreTechnology or Integration · 1 January 2025Uzbekistan Accreditation Center conducted the accreditation process for the Tobacco and Tobacco Substitute Products Testing Department per ISO/IEC 17025:2019. The laboratory was entered into the National Register of Uzbekistan and authorized to perform tobacco and tobacco substitute product testing for Uzbekistan-manufactured products. This accreditation expands the laboratory's recognized testing scope to Uzbekistan.
• Maria Zaitseva (GLP/GCLP Expert, Candidate of Medical Sciences)coreStrategic or Co-development Partner · 1 January 2025Maria Zaitseva, a leading expert in preclinical and clinical research, GLP systems expert, member of the British Association of specialists in scientific and clinical research quality, and Candidate of Medical Sciences, conducted a GLP/GCLP audit of the Drug Quality Control and Bioequivalence Studies Department. Positive results confirmed compliance with international GLP/GCLP requirements.
• Certification and Quality LLCcoreImplementation/ SI/ Consulting Partner · 1 January 2025FDA Laboratory LLC's partner organization Certification and Quality LLC organizes conformity assessment of exported and imported products and issues EAC Certificates of Conformity in accordance with the technical regulations of the Union. They also issue Technical Regulation (AST) Declarations of Conformity within the scope of their accreditation. This partnership enables end-to-end certification services for clients.
• Major biologically active food supplement distribution companies (Almaty, Kazakhstan)minorStrategic or Co-development Partner · 16 September 2024During September 16-20, 2024 conference visit to Almaty, Kazakhstan, B2B meetings were organized with representatives of major companies distributing biologically active food supplements. Opportunities for cooperation and mutual collaboration were discussed for developing a unified regional market.
• Philip Morris KazakhstancoreStrategic or Co-development Partner · 7 April 2024During April 7-11, 2024 working visit to Kazakhstan, cooperation agreements were concluded with Philip Morris Kazakhstan. FDA Laboratory LLC provides tobacco and tobacco substitute product testing services, including testing of filter cigarettes, heated tobacco products, and electronic cigarettes.
• British American TobaccocoreStrategic or Co-development Partner · 7 April 2024During April 7-11, 2024 working visit to Kazakhstan, cooperation agreements were concluded with British American Tobacco. The laboratory provides testing for their tobacco and tobacco substitute products per EAEU technical regulations.
• JTI KazakhstancoreStrategic or Co-development Partner · 7 April 2024During April 7-11, 2024 working visit to Kazakhstan, cooperation agreements were concluded with JTI Kazakhstan. FDA Laboratory LLC is designated by the Ministry of Economy as a conformity assessment body for tobacco substitute product testing.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Bureau Veritas: International testing, inspection, and certification group with significant agri-food, consumer products, and commodity testing operations. Direct peer as a global contract testing firm supporting import/export regulatory compliance.
• Intertek Group: Global testing and certification provider covering food, pharma, cosmetics, and consumer goods with extensive international accreditations. Comparable to FDA Lab in serving manufacturers requiring accredited test reports for cross-border market access.
• ALS Limited: Global testing services provider with food, pharmaceutical, environmental, and consumer-product testing divisions. Comparable multi-discipline contract testing business model serving regulated industries.
• SGS SA: One of the world's largest testing, inspection, and certification companies, with strong food, pharma, and consumer-product testing portfolios. Direct comparable on multi-product contract testing services for manufacturers and exporters.
• Eurofins Scientific: Global leader in contract laboratory testing for food, pharma, cosmetics, and environmental samples. Highly comparable to FDA Laboratory as a multi-discipline accredited testing services provider serving regulated-product manufacturers worldwide.

Regional players

• Pharmaron: China-headquartered CRO/CDMO with bioanalytical and drug development laboratory services serving global pharma. Comparable on bioanalytical / drug QC testing service layer, though serves primarily Asia-Pacific and US clients rather than Armenia/EAEU.

Broad incumbents

• IQVIA: Global CRO with integrated central laboratory, bioanalytical, and clinical research services supporting pharma drug development. Comparable to FDA Lab's bioequivalence and clinical research central lab capabilities within a much broader CRO portfolio.
• ICON plc: Major global CRO providing bioanalytical laboratory services, clinical research, and central laboratory capabilities to pharmaceutical and biotech clients. Comparable on the bioequivalence / central lab service layer that FDA Lab offers to CROs and pharma.
• Charles River Laboratories: Major contract research organization with extensive bioanalytical and bioequivalence testing capabilities for pharmaceutical clients. Comparable to FDA Lab's GLP bioequivalence laboratory and CRO service offering, though at vastly larger scale.
• Labcorp Drug Development: Large clinical laboratory and CRO with extensive bioanalytical and central lab capabilities serving pharma clients globally. Comparable on regulated laboratory testing and drug development analytical services, though much broader in scope.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/channel/UC5oFThAcWhWm0sd9Z3vtm3g
• Facebookfacebook.com/FDALaboratoryArmenia
• LinkedInlinkedin.com/company/fda-laboratory-llc
• Instagraminstagram.com/fda_lab

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

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 FDA Laboratory LLC