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.
Spectroscopy
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.
