Acceptance
The FDA Modernization Act allows summary data to be presented to the FDA in lieu of the entire report. In cases where detailed information is requested, you may be required to follow-up with the actual study report. The certificate does not replace the study report, but will be accepted as a summary.

The primary purpose of the certificate is to ensure that all testing within a study/program was conducted in strict compliance with the applicable standards. However, if a client has already obtained some testing data from another source, NAMSA may still be able to offer this certificate with a review of the test data and protocols generated by other sources.

Fees
There is no charge for the certificate of compliance when testing is performed according to NAMSA’s test program proposal. However, in the event that test data from other sources or literature information requires review, there may be a consultation charge.

Timing
The Certificate is available for ISO 10993 - compliant test programs as the testing is conducted and the data recorded. The certificate will be sent with the completed lab report from the final study of your test program. To obtain your NAMSA Certificate of Compliance, simply ask your GLP study director, upon accepting the test proposal.