Our client, headquartered in the USA, is a mid-sized biopharmaceutical company specializing in clinical-stage precision therapeutics as they work to meet the needs of patients suffering from oncology and autoimmune related diseases.

The client was seeking US FDA approval for a Phase I clinical study to be conducted in the USA and needed to prepare and file an eCTD dossier to support the IND Application. With a predefined, and very short submission window, the client engaged with Navitas Life Sciences to provide End-to-End IND Regulatory and Medical Writing Services.

Please complete the form to download the case study and learn how we provided end-to-end IND Regulatory and Medical Writing Services to secure approval for a Phase I study to proceed. 

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