Specialist pharmaceutical analysis services to support development programs (R&D), regulatory submissions, GMP manufacturing and post-marketing requirements
Pharmaceutical analysis plays an important role in both the development process and GMP manufacturing. Concerns about drug safety, costly development programs, complex manufacturing, market demands for evidence-based data and increased regulatory requirements are all issues that can be addressed through a better understanding of your drug substance, drug product or manufacturing process which, in turn, can only be achieved through experienced analytical studies and robust analytical data.
Our contract pharmaceutical analysis services are focused on supporting product development, GMP manufacturing and distribution, from an early phase of development through to manufacturing and post-marketing analytical support.
With our specialist pharmaceutical analysis capabilities for complex products such as ocular implants, pharmaceuticals, biopharmaceuticals, oligonucleotides, inhalation drug products, medical devices, vaccines and regenerative medicines, we can help to accelerate your development process, achieve the right data to complete marketing authorisation submissions and support your post-marketing requirements. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
CMC Analytical Suport
We provide regulatory-driven, phase-appropriate analysis in support of CMC programs which include method development and validation, stability programs and extractables and leachables. Supporting formulation and manufacturing, our pharmaceutical powder and particle characterisation, cGMP quality control tests and cGMP batch release testing help to qualify raw materials used in processes and establish that products meet quality specifications. Our experts provide determination and quantification of impurities such as elemental impurities and residual solvents through the latest regulatory compliant methods.
Formulation Development, Clinical Trial and Analytical Support
Through our integrated formulation development, analysis, stability studies and clinical batch manufacturing capabilities we can screen a wide range of formulations in a timely and cost-effective manner in order to identify the most promising formulation to progress through to further development and pilot batch manufacturing. These programs involve method development & validation, excipient compatibility studies, accelerated stability studies and ICH real time stability. Following pilot batch manufacturing and testing, our GMP clinical batch manufacturing combined with batch release testing and QP release present an efficient, one-source solution for supplies for use in Phase I and II clinical trials.
Post-Approval and Manufacturing Analytical Support
With a long history of GMP batch release testing, our highly skilled scientists tailor our release testing programs to your requirements and can provide services for the most basic of tests through to more specialised techniques. Our flexible model for providing routine raw material GMP quality control testing, gives you access to on-going QC testing resources, or extra capacity for you, during times of heavy workload.
Our analytical scientists have significant expertise in the development and validation of new methods and comparison with existing methods to accommodate your analytical method lifecycle and manufacturing changes, responding flexibly to changes in regulation and evolving technological capabilities.
Our cleaning validation analytical services support manufacturing with highly specific and sensitive GMP quantification of detergents, cleaning agents and pharmaceutical product residues.
With responsive pharmaceutical investigational analysis expertise, we work to rapidly address and resolve contamination issues through a forensic process involving trace analysis techniques and microscopy services to identify what the contamination is, where it exists and how to prevent it from happening in the future.
As part of our pharmaceutical supply chain surveillance services, our falsified medicines analysis expertise is ideally positioned to investigate the increasingly sophisticated falsified medicines or counterfeit medicines being discovered in legitimate supply chains.
Research and Development Analytical Suuport
With considerable experience in molecular structure elucidation and identification and specialist analytical technology such as nuclear magnetic resonance or mass spectrometry, we can confirm identity or determine the structure of a new substance or an impurity. From an early stage of development, our solid state characterisation, analytical method development and validation and formulation development expertise can help to characterise pharmaceutical materials including powders or nanoparticulates. Combined with other analytical techniques, this can help address problems that might otherwise only be observed in the later phases of the development process. We have specialist capabilities
Your pharmaceutical intellectual property protection is important. With our chemical analysis and imaging expertise combined with our pharmaceutical investigational analysis and expert witness services, we can deliver the insight you need into complicated pharmaceutical materials and products to support legal cases.
Our unrivalled knowledge of packaging materials including plastics, elastomer closures, glass and board help to identify, quantify and minimize harmful impurities which could leach from container closure systems and packaging into products through screening controlled extractables studies.
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Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Formally confirming that your products and services meet all trusted external and internal standards.