Five Batch Analysis

The preliminary determination of the analytical profile (screening) may be carried out by Oxford analytical Ltd., or this information maybe provide by the client. Following on from this it would be usal to proceed to the full analysis of the five product batches for purposes of obtaining registration. Method validation would normally form an important part of this service, and can be carried out to meet the requirements of SANCO/3030/99 rev.4.

We offer a service, which is fully GLP compliant and can be tailored to meet specific requirements. The timelines for completion of a five batch study with validation and impurity assay can vary depending on the complexity of the study.

We have a wealth of knowledge in five batch analysis from previous experience and an extensive range of successful historical product registration data.