Analytical Development

At Adragos, we specialize in analytical development, offering a suite of services tailored to the pharmaceutical sector. Our state-of-the-art laboratories are equipped with the latest instrumentation, ensuring all analyses meet the stringent EU-GMP standards and ICH guidelines. Whether you need independent analytical testing or an integrated development package, our expertise guarantees precision, quality, and compliance.

Analytical Development Services

Adragos Athens:
Method development and validation
Forced degradation
Dissolution studies
Chemical analysis of APIs
Finished product controls
Process validation controls
ICH stability, photostability, and in‑use stability
Transfer of analytical methods
Drug product release (EU QP)

Adragos Jura:
HPLC‑UV (assay, purity)
Subvisible particle counting
Osmolality
Water content
UV‑Vis and IR spectrophotometry
pH
SDS‑PAGE
Thin‑layer chromatography
Potentiometry
Viscosity
TOC (total organic carbon)
Sterility testing under isolator
Endotoxins
Biocontamination testing
Testing for specified microorganisms

Technologies

• Empower® Chromatography Data System 
• Liquid chromatography (PDA, RID, or UV) 
• Ultra-Performance Liquid Chromatography (UPLC) 
• Ion Exchange Chromatography (IEC) 
• Liquid Chromatography–Mass Spectrometry (LC MS) 
• Gas Chromatography (GC) for Headspace or liquid injections (ECD and FID) 
• UV spectrophotometry  
• Dissolution testing (USP I, II & III) 
• Walk-in stability rooms and stability chambers 
• Photo stability chamber 
• Differential scanning calorimetry 
• Optical microscopy 

Tailored Analytical Solutions

We understand the critical role of analytical services in drug development. Our laboratories deliver a broad range of analytical capabilities designed to address specific client requirements effectively. Every service adheres to rigorous quality controls and regulatory standards, providing reliable support for pharmaceutical innovation.

Validation and Support Services

Enhancing drug formulation and development, our analytical services team leverages advanced technology and deep scientific knowledge to offer robust validation of analytical methods. This comprehensive support ensures that all procedures meet global regulatory expectations and help streamline the path to market for new pharmaceutical products.

Certification and Compliance Assurance

Our facility and processes comply with all relevant GMP standards, including rigorous operational and performance qualifications annually. We also uphold the highest standards for computerized systems and data integrity, ensuring that our services meet all regulatory and quality benchmarks.

Flexible Analytical Service Options

We provide exceptional analytical services for pharmaceutical development. Our commitment to excellence in analytical development ensures that we deliver superior quality and compliance in all aspects of pharmaceutical testing and development.

Our network for analytical development services

With more than 3,000 m² of R&D facilities, Adragos Athens specializes in the development of value‑added medicines and was recently equipped with HPAPI capabilities.

We provide manufacturing solutions for the most demanding commercial needs—from vials to lyophilization—including optical and biological products. In addition, we specialize in small‑batch production with a tailor‑made approach.

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