What is the qualification requirement for testing labs for non-clinical research?

Initial registration submission dossier, Chapter 3 is for the Non-Clinical Research Material. In this chapter, the test report we submitted does not have to be performed or generated by the manufacturer itself. The manufacturer can engage an external lab to complete the test. There is no specific requirements for the qualification of the external lab.

Examples of test: virological test, immunological test.

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What Is The Qualification Requirement For Testing Labs For Non-clinical Research?

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