Certara Synchrogenix
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Certara Synchrogenix assures and accelerates the approval of and access to medical innovations through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, and operations solutions. Our proven record of success is built on an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency.
With industry experts across the full product development lifecycle in North America, Europe and Asia Pacific, we provide the flexibility, scalability and round-the-clock support sponsors need to meet changing requirements and timelines.
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regulatory writing, strategic document development, clinical trial disclosure, support of modules 15 of ctd, medical writing, scientific writing, submission leadership nda, maa, bla, ind, anda, 505b2, redaction, artificial intelligence, regulatory operations, publishing, regulatory consulting, pmta, mrtpa, ectd
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