Analytical Services


Analytical servicesFrom our state-of-the-art analytical laboratories in the UK and US, our highly skilled analysts deliver comprehensive solutions to support drug substance (API) and drug product development programs. Analytical and microbiological testing solutions for clinical and commercial drug product supply are also provided.

Our Skilled Professionals

We employ over 250 highly trained analytical scientists with expertise in all areas of drug development, including small molecules, peptides, conjugates and potent materials. Drawing upon our vast pool of scientific knowledge, we can greatly reduce the analytical challenges that typically arise during drug development.

Communication and scientific continuity is key, whether your analytical requirements are stand-alone or form part of a drug development or commercial manufacture project. Our analytical scientists work with our API / drug product formulation scientists, forming an integral part of the project team. This means they can share data, easily coordinate planning and scheduling, and deliver maximum efficiency.

Our Comprehensive Services

We support drug substance and drug product development from early phase to commercialisation and beyond. This includes:


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Physical and Chemical Characterisation
Method Development and Validation
Clinical and Commercial Analytical Support
Stability Testing
Physical and Chemical Characterisation

Physical and Chemical Characterisation

A Diverse Range of Techniques to Suit Your Reference Material

Our state-of-the-art laboratories and highly experienced scientific staff can identify and fully characterise reference standards, APIs (small molecules and peptides), impurities, powders, tablets, capsules, creams and liquids. Most often, our work involves identifying an impurity from the manufacturing process, degradation products formed during storage or the full chemical and physical characterisation of a reference material.

Using a diverse range of analytical techniques, we will identify and fully characterise the following:

  • Impurities, including genotoxic impurities
  • Degradation products
  • APIs
  • Peptides
  • Excipients
  • Salt forms
  • Polymorphs
  • Particle size and shape

Accurately Identifying Degradation Products, Impurities and Metabolites

Our dedicated GMP, MS, and NMR facility routinely performs the identification of degradation products found during stability testing, the impurities found during API and drug product testing, and the metabolites found during bioanalysis. Structural elucidation and chemical characterisation of compounds using MS, NMR and IR are carried out on a daily basis.

We use our vast knowledge of process chemistry to help determine the likely source of impurities, and we provide the process optimisation skills to eliminate them. We also have the instrumentation and synthetic capabilities to isolate or manufacture  impurities.


Method Development and Validation

Method Development and Validation

Developing and Validating 180 Drug Substances and Drug Product Methods Each Year

Our analytical team has a proven track record in rapid method transfer, method development and method validation.

Working closely with our clients, we deliver robust, efficient, stability-indicating and fit-for-purpose analytical methods. We fully understand and comply with the analytical support demanded by regulatory authorities at each stage of the drug product lifecycle.

Our unique blend of experience, expertise, and focus enables us to deliver, reliable, information-rich methods to meet your exact requirements. Typical analytical techniques include, but are not limited to:

  • HPLC and U(H)PLC
  • Ion Chromotography
  • Q-NMR
  • Dissolution (USP apparatus 1 and 2)
  • LC-MS / GC-MS
  • Particle size by laser diffraction
  • GC
  • Volumetric/ Coulometric KF
  • XRPD
  • Potentiometric Titration
  • UV Spectrophotometry
  • Fluoresence Spectrophotometry
  • ICP-MS

Utilising the extensive library of in-house methods, statistical exploration tools, and emerging analytical technologies, such as UPLC™ and Empower 2, we can reduce your method development, validation time and associated costs while generating accurate and reliable data.


Clinical and Commercial Analytical Support

Providing Quality Release Analysis for Your Drug Substance or Drug Product

We are regarded as the high quality and low risk analytical service provider of choice for the release testing of clinical and commercial supplies. Our proven and extensive expertise supports a diverse range of dosage forms, including:

  • Tablets and capsules
  • Powders and granules
  • Liquids
  • Parenterals

Analysis techniques include:

  • HPLC / H(U)PLC
  • GC (with headspace)
  • Ion chromatography
  • Karl Fischer water determination
  • Autotitration
  • Identity by FTIR, 1H NMR, 13C NMR, 19F NMR, 31P NMR, XRPD and MS
  • LC-MS / GC-MS
  • Dissolution
  • ICP-MS
  • Particle size
  • Quantitative NMR

We are also able to support elemental analysis for the updated USP<232> and USP<233> chapters, with the use of fully GMP ICP-MS.

The synergy with our clinical trial supply services enables the rapid and effective analytical support for comparator testing, including method development and release.


Stability Testing

Stability TestingExtensive Experience in Providing a Comprehensive GMP Stability Service

Our all-inclusive stability service encompasses protocol design, analytical method transfer, study management, sample analysis and QA approved reporting, taking into account transport simulation and in-use stability programmes.

Our UK and US state-of-the-art, walk-in stability chambers provide ICH-compliant, climatic storage facilities for all of your requirements.

  • 25°C / 60% RH
  • 30°C / 65% RH
  • 30°C / 75% RH
  • 40°C / 75% RH
  • 5°C
  • -20°C
  • Photo-stability

At any given time, our dedicated team may supervise as many as 150 or more stability programmes. From early phase material to validation and commercial batches, all conditions are continually monitored and employ back-up systems to ensure a secure and controlled environment.




More Details

Physical and Chemical Characterisation
Method Development and Validation
Clinical and Commercial Analytical Support
Stability Testing
Physical and Chemical Characterisation

Physical and Chemical Characterisation

A Diverse Range of Techniques to Suit Your Reference Material

Our state-of-the-art laboratories and highly experienced scientific staff can identify and fully characterise reference standards, APIs (small molecules and peptides), impurities, powders, tablets, capsules, creams and liquids. Most often, our work involves identifying an impurity from the manufacturing process, degradation products formed during storage or the full chemical and physical characterisation of a reference material.

Using a diverse range of analytical techniques, we will identify and fully characterise the following:

  • Impurities, including genotoxic impurities
  • Degradation products
  • APIs
  • Peptides
  • Excipients
  • Salt forms
  • Polymorphs
  • Particle size and shape

Accurately Identifying Degradation Products, Impurities and Metabolites

Our dedicated GMP, MS, and NMR facility routinely performs the identification of degradation products found during stability testing, the impurities found during API and drug product testing, and the metabolites found during bioanalysis. Structural elucidation and chemical characterisation of compounds using MS, NMR and IR are carried out on a daily basis.

We use our vast knowledge of process chemistry to help determine the likely source of impurities, and we provide the process optimisation skills to eliminate them. We also have the instrumentation and synthetic capabilities to isolate or manufacture  impurities.


Method Development and Validation

Method Development and Validation

Developing and Validating 180 Drug Substances and Drug Product Methods Each Year

Our analytical team has a proven track record in rapid method transfer, method development and method validation.

Working closely with our clients, we deliver robust, efficient, stability-indicating and fit-for-purpose analytical methods. We fully understand and comply with the analytical support demanded by regulatory authorities at each stage of the drug product lifecycle.

Our unique blend of experience, expertise, and focus enables us to deliver, reliable, information-rich methods to meet your exact requirements. Typical analytical techniques include, but are not limited to:

  • HPLC and U(H)PLC
  • Ion Chromotography
  • Q-NMR
  • Dissolution (USP apparatus 1 and 2)
  • LC-MS / GC-MS
  • Particle size by laser diffraction
  • GC
  • Volumetric/ Coulometric KF
  • XRPD
  • Potentiometric Titration
  • UV Spectrophotometry
  • Fluoresence Spectrophotometry
  • ICP-MS

Utilising the extensive library of in-house methods, statistical exploration tools, and emerging analytical technologies, such as UPLC™ and Empower 2, we can reduce your method development, validation time and associated costs while generating accurate and reliable data.


Clinical and Commercial Analytical Support

Providing Quality Release Analysis for Your Drug Substance or Drug Product

We are regarded as the high quality and low risk analytical service provider of choice for the release testing of clinical and commercial supplies. Our proven and extensive expertise supports a diverse range of dosage forms, including:

  • Tablets and capsules
  • Powders and granules
  • Liquids
  • Parenterals

Analysis techniques include:

  • HPLC / H(U)PLC
  • GC (with headspace)
  • Ion chromatography
  • Karl Fischer water determination
  • Autotitration
  • Identity by FTIR, 1H NMR, 13C NMR, 19F NMR, 31P NMR, XRPD and MS
  • LC-MS / GC-MS
  • Dissolution
  • ICP-MS
  • Particle size
  • Quantitative NMR

We are also able to support elemental analysis for the updated USP<232> and USP<233> chapters, with the use of fully GMP ICP-MS.

The synergy with our clinical trial supply services enables the rapid and effective analytical support for comparator testing, including method development and release.


Stability Testing

Stability TestingExtensive Experience in Providing a Comprehensive GMP Stability Service

Our all-inclusive stability service encompasses protocol design, analytical method transfer, study management, sample analysis and QA approved reporting, taking into account transport simulation and in-use stability programmes.

Our UK and US state-of-the-art, walk-in stability chambers provide ICH-compliant, climatic storage facilities for all of your requirements.

  • 25°C / 60% RH
  • 30°C / 65% RH
  • 30°C / 75% RH
  • 40°C / 75% RH
  • 5°C
  • -20°C
  • Photo-stability

At any given time, our dedicated team may supervise as many as 150 or more stability programmes. From early phase material to validation and commercial batches, all conditions are continually monitored and employ back-up systems to ensure a secure and controlled environment.