Raw Material In-Process Release Testing

Raw Material In-Process Release Testing

Method Transfer & Validation

All new drugs require appropriate tests for accurate measurement of their ID and concentration. This requires that the assay that is being performed is rugged enough to produce consistent results that are reliable. BSM will work with your team to transfer methods under the oversight of BSM’s Quality Control group and reviewed by our Quality Assurance group. We will issue Certificates of Analysis (CoA) with the documentation necessary to stand up to rigorous review by outside parties.

Assay or Validation / Transfer or Validation

BSM will perform a transfer of the method to our laboratory. Site to site assays as well as multiple operator testing are required to ensure that the results are consistent. If the test is determined to not be rugged enough for GLP or GMP standards, BSM analytical staff will work with you to develop an assay to provide for standard testing to ensure purity, quality and strength each time the assay is performed.

BSM will work with you and your team to ensure that your drug test’s meet the same criteria
for quality standards set forth by the various regulatory agencies.