We offer high-quality analytical testing solutions for pharmaceutical and biopharmaceutical products through all phases of drug development, from discovery through early development and commercialisation.
Our bespoke testing and clinical service offering, which covers full clinical development from Phase I first-in-human trials to Phase II and Phase III studies in patients, provides reliable and accurate results that ensure the safety of your products and protect patient health. Our experts, working with small and large molecules, use the latest equipment and techniques at our state-of-the-art laboratories and clinical trial facilities in North America, Europe and Asia- Pacific. They can assist throughout the development process, providing a range of mission-critical formulation and manufacturing services. We also offer expert guidance from our experienced consulting and project management teams, so you can get your products to market quickly, safely and cost-effectively
Using the latest technologies and state-of-the-art equipment, our scientists ensure the quality and safety of pharmaceuticals and biopharmaceuticals during all phases of drug development. We offer a wide portfolio of services, including:
• Method development and validation
• Analytical chemistry
• Microbiology testing
• Stability testing
• Bioavailability enhancement
• In vitro toxicology
• Extractable and leachables testing
• Medical device testing
Our global centers of excellence will cover your testing needs for specific biopharmaceutical products, including vaccines, cell and gene therapies, biosimilars and other biologic products. The solutions that we offer include:
• Structural characterisation and confirmation
• Qualitative and quantitative impurity analyses
• Physicochemical properties analysis
• Biosafety testing
We specialize in the development and manufacture of innovative new chemical entities, biologicals and live biotherapeutics for global markets. We offer solutions around:
• Preformulation and CMC support
• Formulation development (and the development of supporting analytical methods)
• Bioavailability enhancement
• Dosage form optimisation, improvements and differentiation
• First-in-human supply
• Process optimisation
• Clinical, specials and commercial manufacturing (including packaging and supply)
We run clinical trials all the way from study design to clinical trial execution, delivery of the final data analysis and producing a clinical study report. Our experts are available to support your studies and to assist with all aspects of formulation development:
• Drug development consultancy
• Early-phase clinical development
• Biometrics support
• Global clinical trial management
• Scientific expertise: We provide a diverse range of trusted formulation development, analytical testing, phase-appropriate manufacturing and clinical research solutions that match your needs and help you navigate your journey to market.
• Integrated CRO network: Using state-of-theart equipment, our scientists and experts verify the quality, efficacy and safety of therapeutics by providing comprehensive solutions within an integrated CRO network. This encompasses everything from exploratory development and clinical development to commercial QC and postmarket testing.
• Accelerated drug development: We use innovative techniques that provide patients with better, safer treatments and contribute to your organisation’s success.
• Global regulatory compliance: Through our global network of laboratories and clinical trial facilities, we offer integrated services and expertise that provide organisations with knowledge, flexibility and the ability to scale while staying compliant at all times.
• Customer focus: Our specialists deliver multifaceted, customer-centric programs at local and international levels – supporting your commitment to delivering high-quality, compliant biopharmaceutical and pharmaceutical drugs and medical devices.