Issue Date: December 13, 2017
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Draft
Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry
Download the Guidance Document
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Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.
