Regulatory Publishing Expertise for an Efficient NDA Submission Process

Veristat supported a commercial stage biopharmaceutical company in NDA submission, bringing regulatory publishing expertise for a new therapy being developed for the acute treatment of schizophrenia or bipolar disorder-associated agitation.

This partnership was a result of Veristat’s successful regulatory consulting services on a previous engagement. The current project was transferred to Veristat from the sponsor’s former vendor, and all content provided needed substantial review and modification to meet FDA submission requirements.

Our consulting activities successfully drove NDA submission to FDA Approval. The therapy is now on the market in the U.S. as the first acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade. Veristat continues to support the sponsor in pursuing the expansion of this product for three additional indications, providing regulatory and strategic consulting for INDs, FDA meetings and advancing clinical development plans.

Efficient Regulatory Publishing throughout the Product Lifecycle leads to NDA Approval

A successful NDA submission requires a well-planned roadmap and timeline. Collaborating with Veristat Regulatory Strategy, Regulatory Publishing, Medical Writing, and Project Management experts early and regularly helped ensure a flawless final submission.

Access the full case study to learn how Veristat overcame the challenge of missing data sets and non-compliant documentation quickly and effectively to meet FDA submission requirements.

Veristat is an expert in supporting the publishing of your applications, amendments, supplements, and reports to the regulatory agencies. We offer publishing as an independent service or as part of our end-to-end regulatory solutions, providing strategic regulatory consulting, developing all submission documents/dossiers and publishing them to the regulatory agencies.