We provide an unrivalled breadth of analytical solutions, techniques and applications to the Pharmaceutical, Medical Device and Advanced Wound Management healthcare sectors.
Our unique blend of solid state, chromatographic and compendial test methods provides comprehensive analytical solutions to the Pharmaceutical industry; from early lead optimisation / drug candidate selection through to cGMP commercial release of Finished Products and raw materials. We provide services to both Human and Veterinary Pharmaceutical companies.
Key analytical and adjacent services include:
- Pre-formulation (API characterisation, salt/polymorph/crystal & co-crystal screening and solubility determination in biorelevant media)
- Early formulation studies including excipient compatibility screening, excipient & formulation screening for enhanced exposure of poorly soluble drugs
- Micronisation and analytical characterisation of pulmonary APIs
- De-formulation analysis as part of our ANDA support package
- R&D preparation of powder blends, solutions, suspensions and capsule filling
- Method development and stage-appropriate method validation and transfer
- Extractables and leachables testing
- Impurity and metabolite identification synthesis.
- GLP release testing of pre-clinical formulation
- Bioanalysis – from new method development and validation through to GCP-compliant analysis of clinical samples
- Reference standard provision and certification
- Release testing of raw materials and finished products to Europe and the US under our MHRA cGMP certification and FDA Establishment Identifier status
- Manufacturing support services; decontamination and cleaning validation, occupational hygiene, particulate & microbial monitoring, environmental analysis and unknown contaminant identification
- Pharmaceutical microbiology
- ICH stability studies; storage, analysis and reporting
Further details of the equipment and applications available at Concept Life Sciences are given below.
We provide a wide range of analytical services to the medical devices sector, particularly for implanted materials such as bone substitute and silica through to drug compounding devices. Example services include:
- Identification, phase purity and residual heavy metals by XRF/XRD and ICP
- Cleaning validation studies
- Container closure integrity testing
- Closed System Transfer Device effectiveness testing
We work for a number of global AWM companies providing the following services:
- Release testing of raw materials and finished products (e.g. collagen testing)
- Micronisation and analysis of silver containing anti-microbial agents
- Proposition 65 chemical safety testing