Elevate Efficiency and Efficacy With Our Robust Analytical Services

SK biotek Ireland Analytical Services offers Analytical Assistance to API and other Intermediates through Product Development, Testing and Validation

Key Services of SK biotek Ireland Analytical Services

Method Development & Validation

SK biotek Ireland Analytical Services offer fast and efficient Method Development and Validation services that comply with regulations.  

Taking the development phase into consideration, our experts provide the ideal solution to your requirements.

Reference StandardS

Through characterisation, certification, expiry dating, periodic re-qualification, storage, and distribution, 

we support customer reference standard initiatives.  SK biotek Ireland Analytical Services offer CGMP qualification and characterisation services to establish the identity and potency of Primary Reference Standards (PRS). 

Physical Characterisation

Researching and validating the physical properties of a wide range of substances is a specialty of SK biotek Ireland Analytical Services.  We provide sophisticated solid-state characterisation analysis of form, particle size distribution, surface area, porosity, thermal behaviour, flow pattern, and more.

ICH Stability & Forced Degradation

Select the required level of stability or forced degradation support with SK biotek Ireland Analytical Services.  Profit from our experience with forced degradation and stability studies for pharmaceutical active components.  With your needs in mind, we can create and provide advice on all of your stability requirements.

Release Testing

SK biotek Ireland Analytical Services have extensive experience undertaking robust Release Testing on commercial goods and clinical materials. We offer a comprehensive range of Release Testing services for evaluating drug substances, intermediates, and raw materials.

Compound CharacteriSation

Addressing the unique needs of our clients, we provide an extensive array of analytical procedures for Compound Characterisation.  SK biotek Ireland Analytical Services’ advanced XRPD, NMR, and FTIR equipment helps fully characterise compounds to support all CGMP requirements.

Elemental Impurities ICP-MS/OES

Detect impurities at a parts-per-trillion level by utilising our state-of-the-art analytical services. 

SK biotek Ireland Analytical Services offers ICP-OES, ICP-MS, Chromatography, NMR Spectroscopy, Material Characterisation, powder X‐ray Diffraction and Foreign Matter Identification amenities.


To assist with your drug development, clinical testing, or commercial testing, SK biotek Ireland Analytical Services provide a broad range of spectroscopy analysis services.  Leverage our NMR, FT-IR, ATR-IR, Raman Spectroscopy, Near-IR or XRPD expertise.

SK biotek Ireland Analytical Services Offering

  • cGMP Testing Services, including Highly Potent compounds (< 0.1 µg/m3

  • State-of-the-art Techniques and Instrumentation 

  • Highly-trained and experienced analysts supporting Release Testing and Method Development

  • Method Development using Quality by Design (QbD) concepts following ICH Q14 principles 

  • Method Validation according to ICH Q2 Guidelines 

  • API and Intermediate Release Testing 

  • Elemental Impurity Analysis

  • ICH Stability and Forced Degradation Studies 

  • Compound Characterisation XRPD/NMR/FTIR

  • Physical Characterisation

  • Full offering of compendial testing methods (USP/EP/BP/JP)

  • Spectroscopy Services

  • Project Management Services like:

    • ICH Q10-based Quality Management System 

    • Single Point-of-Contact Services that ensure smooth and efficient communication within teams

    • Regulatory Support that successfully navigates you through administrative processes

Innovation That Highlights Precision

Based in Swords, County Dublin, SK biotek Ireland Analytical Services are your one-stop solution to all your API and Intermediate product development and testing needs.  With over 60 years of Active Pharmaceutical Ingredients (API) manufacturing experience, our Analytical Research Contract Services facilitates:

  • Process Development and Commercial Manufacturing

  • Analytical Support throughout the product lifecycle

  • Innovative ways to optimise analytical performance, following QbD and ICH Q14 Guidelines.

Leverage Our Cutting-Edge Equipment

Life at SK biotek Ireland Analytical Services

SK biotek Ireland Analytical Services offers 60 years of continuous technical competence as a provider of drug substances.  We have CGMP labs with the latest equipment and a proven track record in quality, health and safety.  We execute a broad spectrum of services to support products at different stages of development while ensuring a bespoke and all-round service.

All stages of development receive exceptional and thorough support from our Analytical Teams in Dublin, Ireland.  Our wide selection of cutting-edge analytical instrumentation and trained experts allow us to focus on flexibility while meeting every project need.  

SK biotek Ireland Analytical Services strives to provide customers with robust analytical methodologies and takes pride in delivering innovative solutions.

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