Relieving The Strain Of Publishing During Regulatory Registration

In this case study, learn how Veristat successfully managed an NDA submission for a biopharmaceutical company developing a therapy for bipolar disorder and schizophrenia. When the project was transferred to Veristat from another vendor, the content required extensive review and modification to meet FDA requirements. Veristat’s team collaborated closely with the sponsor’s regulatory manager to establish a robust process roadmap, reformatting documents, and ensuring compliance with CDISC standards.

Despite unexpected FDA information requests, Veristat's strategic management enabled the team to regain time and achieve timely approval. This partnership exemplifies Veristat's expertise in regulatory publishing, strategic consulting, and project management, leading to a flawless submission and ongoing support for additional indications.