Our services provide answers for the whole pharmaceutical lifecycle – from early phase, through to manufacturing and post marketing analytical support. Our pharmaceutical analysis services follows the Good laboratory Practice (GLP) where compliant methods can be developed, validated and implemented from routine to high complex samples to support your Chemistry, Manufacturing and Controls (CMC) challenges.
Pharmaceutical Analysis for your research and development needs
Assay and Stability Indicating Method Development and Validation – to GLP regulations for pharmaceutical analysis of intermediates, API’s, formulations and finished products (including injectable solutions, solid dose forms and a host of novel delivery systems). Methods can be developed and validated in accordance with either client-specific protocols or internal SOPs, and all methods are validated to meet MHRA, FDA and/or ICH guidelines.
Assay, Purity and Content Uniformity Testing - for the quality control of pharmaceuticals, APIs, drug substances, excipients, raw materials according to GLP requirements.
Analytical Method Evaluation, Improvement and Redevelopment – Analytical Methods associated with established pharmaceutical products should be continuously evaluated during the product lifecycle for validation status, efficacy and efficiency. In accordance with ICH guides ICH Q2(R1) we are able to evaluate existing methods to highlight performance or efficiency shortcomings. We can then re-optimize, revalidate and transfer the method back to your research or manufacturing facility.
Pharmaceutical analysis of Counterfeit Medicines and Label Claim Analysis- We undertake chromatographic , mass spectrometric and spectroscopic analysis of counterfeit medicines to address the highly technical issues in investigating the increasingly sophisticated falsified medicines or counterfeit medicines being discovered in the supply chains. Our analytical tools allow us to determine the presence of active pharmaceutical ingredients (API’s) as well the amounts of API, impurities, degradants, excipients and other ingredients such as coatings. Our data can be used in support of patent litigation.
We also undertake method development and routine testing in support of cleaning validation, comparator and stability studies.