Analytical Services

Delivering the Data Behind Every Decision

We deliver phase-appropriate analytical solutions that give you clarity and confidence in your molecule, ensuring it is fully understood, controlled, and ready to meet your next milestone.

From discovery through GMP testing, our analytical expertise underpins every stage of development, providing the precision and assurance needed to move forward with confidence.

Analytical Services

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Underpinned by analytical excellence
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Analytical science provides the clarity and understanding needed to make informed decisions and maintain quality throughout development.

At CatSci, we design analytical strategies that are robust today and validation-ready tomorrow. Curated for complex standalone programmes or fully integrated within your wider development project, our scientists combine deep technical expertise with advanced digital tools and ICH Q14-aligned approaches to deliver insight you can trust – from discovery profiling and impurity elucidation to solid-state analysis, stability testing, and full method validation.

Whatever your modality, we bring the same precision and partnership. Whether you’re developing a complex peptide, a challenging oligonucleotide, a highly potent API, or a small molecule, our tailored analytical strategies anticipate the unique challenges of each platform. We work seamlessly with your development teams to ensure your analytical data stand up to regulatory scrutiny and set you up for lasting success.

Talk to us about analytical strategies that deliver confidence

Drug Development Underpinned by Analytical Excellence

Discovery & Early Development
Process Development
Scale-Up & Characterisation
GMP Analytical & QC Testing
Tech Transfer & Regulatory Enablement
Digital and Data-Driven Analytics

Discovery & Early Development

Our discovery analytics, including chromatographic assays such as ChromLogD and peptide or oligonucleotide profiling, enable phase-appropriate characterisation of purity, stability, and identity. Using statistical design and predictive modelling, we generate data that guides candidate selection and shortens the path to lead optimisation.

Process Development

Fully integrated with chemistry teams, our analytical scientists apply QbD principles and DOE-driven method optimisation to deliver robust, scalable processes. Real-time impurity tracking, manufacturability insight, and continuous digital data feedback enable informed decisions and faster scale-up readiness.

Scale-Up & Characterisation

We combine stability studies, polymorph and salt screening, and particle characterisation with digital trending and statistical evaluation to define Analytical Target Profiles (ATPs) and Critical Quality Measures (CQMs). This approach strengthens control strategies and ensures consistent performance as projects move toward GMP manufacture.

GMP Analytical & QC Testing

We provide accurate, compliant release and stability testing in fully GMP-aligned environments. Our validated, statistically evaluated methods ensure traceable, defensible data and continuous performance verification. Integrated data management ensures long-term method lifecycle control in line with ICH Q14 expectations.

Tech Transfer & Regulatory Enablement

Transfer-ready, ICH-aligned method validation, impurity control, and solid-state packages safeguard submissions and simplify regulatory interactions. Digital method transfer files and performance data packages ensure seamless handovers between development and GMP sites, building confidence with regulators and partners alike.

Digital and Data-Driven Analytics

Digital by design and data-driven by nature, our analytical science unites predictive modelling, statistical optimisation, and connected data workflows. Every method is built around an Analytical Target Profile, ensuring faster development, deeper insight, and lasting confidence from discovery to regulatory submission.

Every modality, every stage, and every milestone relies on analytical insight. Our integrated GMP and non-GMP analytical workflows ensure precision, reproducibility, and continuity.

Capabilities & Offerings

GMP Analytical & QC Testing

End-to-end analytical support from method development to validated GMP QC release, stability, water, and compendial testing – all within digitally traceable, compliance-ready workflows.

Complex Modalities

Custom analytical strategies for oligonucleotides, peptides, HPAPIs, ADCs, TACs, and molecular glues, combining orthogonal LC-MS and biophysical techniques to assure structure, purity, and stability.

Preformulation & Developability

Assess pH-solubility, pKa, lipophilicity (ChromLogD), and solid form to guide selection. Digital, data-rich workflows link early properties to manufacturability, informing salt choice, excipient compatibility, and formulation direction.

Method Development & Validation

Statistically designed, QbD-driven methods aligned to ICH Q14 / Q2(R2). Analytical Target Profiles ensure robustness, transferability, and digital lifecycle control from non-GMP to GMP.

Impurity Assessment & Control

Comprehensive LC-MS/HRMS, GC-MS, NMR, and ICP-MS analysis for Nitrosamines, genotoxic and elemental impurities, forced degradation, and digital impurity trending across the product lifecycle.

Stability Studies

ICH-aligned Q1A(R2) long-term and accelerated programmes monitor CQAs with predictive modelling, defining shelf-life and risk for small molecules, peptides, and oligonucleotides.

Solid-State Analysis

Polymorph and salt screening, XRPD, DSC, TGA, and particle size morphology and flowability characterisation deliver insight into form selection, manufacturability, and product stability.

What You Can Achieve

Protect Patient Safety from the Start

Comprehensive impurity profiling, predictive stability studies, and risk modelling ensure no hidden issues reach patients or partners.

Strengthen Your Intellectual Property

Solid-state insight and impurity control define differentiation, supporting patent defence and regulatory strength.

Predict and Prevent Risk

Statistical design and digital data trending anticipate degradation, impurity, and performance issues long before they affect timelines.

Consistent Confidence Across Every Modality

From small molecules to oligonucleotides and HPAPIs, our integrated non-GMP and GMP analytical frameworks provide continuous, traceable data from discovery to release.

Digital Integrity Throughout

Every result is traceable, auditable, and connected across the lifecycle through our secure digital analytical environment.

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Analytical science is about more than data; it’s about understanding the story it tells and using that to drive progress and make confident decisions. From early discovery to regulatory submission, our mission is to provide the analytical insight that accelerates our customers’ success.

Sam Whitmarsh

Technical Director, Analytical Science & Digital Transformation

Dedicated Analytical Facilities

Chromatography & Detection

HPLC, UHPLC, SFC, and Prep-LC/SFC (mg-kg) with UV, CAD, RI, and ELSD detection deliver quantitative purity, assay, and compositional data across discovery, process, and GMP release testing.

Mass Spectrometry & Structural Characterisation

LC-MS/MS, HRMS (Q-TOF) and NMR (400 MHz) provide accurate mass, molecular structure, and impurity elucidation for complete chemical confidence and reference-standard verification.

Solid-State & Thermal Analysis

XRPD, DSC, TGA, DVS, Mastersizer and microscopy define polymorph, particle, and form stability, securing manufacturability, performance, and solid-form control.

Elemental & Trace Analysis

ICP-MS, Karl Fischer, pH, and headspace GC ensure compliance with ICH Q3D and deliver precise residual-metal, solvent, and moisture quantitation.

Spectroscopy & Material Identity

FT-IR, Raman, UV-Vis, and optical spectroscopy confirm molecular identity, polymorph type, and functional-group integrity, supporting raw-material release and structural confirmation.

Stability & Performance Testing

ICH Q1A(R2) stability chambers, predictive trending, and PAT-enabled monitoring assess shelf-life, degradation, and performance under real-time and accelerated conditions.

Automation, Digital Workflows & Data Integrity

Automated sample preparation, high-throughput screening, and statistically optimised DoE methods accelerate development while digital traceability ensures reproducible, audit-ready results from non-GMP to GMP phases.

Modality-Specific Analytics and HPAPI

Specialised LC, MS, and biophysical assays for oligonucleotides, peptides, HPAPIs, degraders, and conjugates, delivering tailored purity, identity, and stability data for complex therapeutic platforms.

Frequently Asked Questions

What pharmaceutical analytical development services does CatSci provide?

CatSci provides comprehensive pharmaceutical analytical development services and GMP analytical testing across the drug development lifecycle. Our expertise includes method development, impurity profiling, stability studies, solid-state analysis, and ICH-aligned validation. We deliver phase-appropriate and GMP-ready analytical solutions for small molecules, peptides, TACs, oligonucleotides, and hybrid modalities to ensure clarity and confidence from discovery to submission.

How does CatSci ensure regulatory compliance in analytical development?

CatSci’s analytical programmes combine scientific rigour with regulatory precision. All methods are developed and validated in alignment with ICH Q14 and Q2(R2), supported by GMP analytical data packages and full traceability. Our documentation, validation, and QC frameworks meet global regulatory expectations, providing partners and CDMOs with confidence for submissions and audits.

Does CatSci offer analytical support for complex modalities?

Yes. CatSci offers tailored analytical support for complex modalities including oligonucleotides, peptides, HPAPIs, and hybrid therapeutics. Our pharmaceutical analytical development services integrate advanced technologies such as LC-MS, HRMS, XRPD, and particle analysis to provide complete molecular understanding and lifecycle data continuity.

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Speak directly with our scientists about your development challenges and explore how we can support your programme.

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