Analytical Services
To complement our clinical trial services business we offer Method Development and Technical Transfer.
Typical methods include identity, assay, dissolution, moisture testing, related substances and content uniformity.
Other service offerings are comparative dissolution analysis of blinded versus unblinded products and release testing in support of EU Release of clinical trial products. Impurity profiling and identification, development of cleaning verification methods and Microbial methods are included in our suite of services.
Stability Studies include Protocol design in adherence with ICH guidelines: long term, intermediate and accelerated conditions.
Storage of samples in fully mapped, qualified and monitored stability chambers: 25°C/60% R.H., 30°C/65% R.H., 40°C/75% R.H, including data evaluation and summary reporting at each time point. Recommendation on storage/packaging conditions re-test and expiry periods can be provided to our clients.