Our analytical method development services include support for the following:
Outsource with Confidence, Flexible Approach, Cost Effective and Fast..
QCL - Quality Compliance Laboratories Inc., R&D analytical scientists have in average of over 15 years of experience in developing test methods for the pharmaceutical, nutraceutical, cosmetics, and allied industries (including comparator products) and can provide a structured, focused, step-wise approach to the process. Here at QCL, we will find a solution to the challenges of your compound with difficult separations, unusual degradation pathways, or other complex analytical characteristics.
We can develop new test methods or improve existing methods. We can tailor existing test methods to your drug substance or drug product. In addition, we have a long-standing and in-depth experience in developing “stability-indicating” analytical methodologies for active and related substances, by performing forced degradation studies and
assessing and developing the stability indicating power of the
methods on the degraded samples. This step allows that, if
needed, the developed methodologies can be used for both
release and stability testing of API and drug products.
We can compose a development history report to
describe what was successful and what was not in the
method development process. We will also generate a
test method for the development of a new method and, if an existing test method was improved, we will write a new version of the test method.
All our method development activities use the client’s requirements, and/or the EP, JP, USP and ICH guidelines as blueprints. We develop, document and validate against predetermined analytical protocols.
With our capacity and highly knowledgeable experienced staff, we are able to develop the method for your project needs in the shortest time possible. We can also perform routine application of the developed method for testing of samples at QCL or we can transfer the assay to the client, including the required documentation.
Our services include the following activities: