Bioanalytical Testing of Biological Samples within Bioequivalence Studies

ABOUT US

“FDA Laboratory” LLC is an internationally accredited laboratory complex that integrates four specialized laboratories under one roof, including Bioequivalence Studies Laboratory.
We offer a comprehensive range of services in accordance with international standards, supporting the demonstration of equivalence between generic medicinal products and their reference products.
The laboratory ensures full management of all stages of biological sample handling in compliance with EMA and USFDA requirements, as well as Good Laboratory Practice (GLP) guidelines. This compliance has been confirmed through successful audits conducted by competent regulatory authorities.

For Contract Research Organizations (CROs), the laboratory may serve as a Central Laboratory (Central Lab) and organize the secure transportation of biological samples. The laboratory also ensures the procurement of required standards, equipment, and materials, maintaining the highest level of operational quality.
Our specialized team is focused on generating reliable and accurate results, providing an individualized approach and optimal solutions for each project in accordance with study protocol requirements.
The laboratory prioritizes transparency, quality, and compliance with international regulatory requirements, with a continuous commitment to meeting and exceeding partner expectations.

Our Services

The laboratory provides:

Analytical Method Development and Validation

using UPLC–MS/MS Systems in accordance with EMA, USFDA, and EAEU (Appendix No. 85) Guidelines.

In Vitro Testing (Biowaiver)

Within the framework of bioequivalence assessment, Biowaiver studies are performed for medicinal products belonging to Biopharmaceutics Classification System (BCS) Classes I and III.

Pharmacokinetic Analysis

for the Assessment of Bioequivalence and Bioavailability.

Analytical Method Development and Validation for New Active Substances

using UPLC–MS/MS Systems in accordance with the same international standards.

Sample Storage

within the Temperature Range of –20°C to –80°C in accordance with the Client-approved Protocol.

Preparation of Test Reports

which may be issued in Armenian, Russian, or English.

Key Advantages

Due to Armenia’s favorable geographical location, we operate in compliance with both EAEU and EU pharmaceutical regulatory frameworks. This enables the use of our test results within the state registration process of medicinal products, ensuring their recognition in Armenia, Russia, and throughout the entire EAEU territory.

All activities are performed under a competitive pricing policy, with stringent quality control and within optimal timelines.

The reference standards, chromatographic columns, and equipment spare parts used in laboratory testing are procured from the United States and EU countries.

The laboratory and clinic are located within the same facility, at a distance of only 20 meters from each other, ensuring efficient and well-coordinated operations.

Technical Infrastructure

The laboratory is equipped with mass spectrometry instrumentation (Waters Xevo TQ-S micro ACQUITY H-Class System), high-performance liquid chromatography (Waters Alliance® HPLC — e2695 Separations Module, Austria), a dissolution testing equipment (Sotax Dissolution Tester, Switzerland), and other advanced instrumentation, ensuring the accuracy, reliability, and reproducibility of results.
The laboratory maintains an adequate inventory of spare parts and provides in-house equipment maintenance, ensuring uninterrupted operation. All equipment undergoes annual calibration.
We welcome client-initiated audits and are committed to continuous improvement, ensuring stable and long-term collaboration with our partners.