Analytical Expertise

At CatSci, we understand the importance of providing the highest quality analytical data so our customers can bring their life-changing medicines to patients, quickly and safely. 

You can rely on: 

  • Our senior analytical leaders with over 70 years of collective GMP technical experience 
  • An experienced QA manager overseeing all quality aspects 
  • The latest high-end laboratory analytical equipment with validated connected CDS and LIMS system, maintaining data integrity 
  • Full compliance with ICH requirements 

These make us a perfect partner to address any of your small molecule and oligonucleotide project needs, whether it is full pipeline support or standalone analytical projects.   

We deliver value-adding data packages and solutions aligned to the latest version guidelines. From ICHQ14 aligned workflows for throughout the lifecycle of a method, ICHQ3D elemental analysis and batch release to ICH stability testing, extractables and leachables, and oligonucleotides analytical development, CatSci is the analytical partner that you can rely on. 

Discover our Analytical Science Offerings

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Method Development & Validation

We believe the analytical method lifecycle values of ICH Q14 and USP <1220> should be woven into each and every process. That is why we offer bespoke method development, validation, risk assessments and method control strategies tailored specifically to your project needs. We employ digital workflows to reduce method development time and enable detailed understanding of the method parameter space.

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Oligonucleotides

The analysis of Oligonucleotides is a science in its own right. At CatSci, you can leverage our 40+ years of collective experience in Oligonucleotide synthesis and analysis. Whether it is complex sequencing and structural characterisation of novel 100mers, method development and validation for commercial manufacturing, or batch release and impurity analysis of starting materials, we have the expertise to deliver your project.

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Trace Element Analysis

As we strive for safer medicines, reduced regulatory limits lead to ever more sensitive analysis. CatSci is fully aligned to ICH Q3D requirements and can deliver the low-level measurements of trace elements in a variety of sample matrixes.





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Structural Characterisation, Investigational Analysis & Troubleshooting

Unknowns waste precious time and resources. Whether that is clinical trials, manufacturing campaigns, or research programs, we understand the cruciality of hitting your critical milestones. We do not just send you data, our experts take ownership of the analytical challenge and work with you to stay on track, on budget, and to keep patients safe.

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Stability Studies

We offer stability studies to help our customers through IND and NDA submission, with the highest-quality data that you can trust. Our GMP Analytical Science services are core to this. We also offer a wide range of non-GMP physical property testing to build your knowledge base.



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