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Learn how our regulatory affairs team was able to work with a sponsor to build a complete, FDA-compliant IND from scratch. Our collaborative efforts led to successful IND submission and initiation of clinical trials with confidence, preventing potential...
4 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
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When our sponsor acquired an investigational asset from an international company, they faced a critical regulatory challenge: Could clinical data from foreign trials not conducted under a U.S. IND be included in their New Drug Application? The foreign...
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In a recent Trailblazers interview, Cindy Henderson, Chief Strategy Officer at Veristat, shared her inspiring career journey from the mailroom to the executive team. Her story is packed with insights for anyone working in clinical research—from clinical...
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In today’s regulatory climate, reports of staffing shortages and slowed review timelines at the FDA have sparked anxiety across the biopharma industry — especially for sponsors preparing for key submissions like INDs or NDAs. At Veristat, however, our...
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The FDA’s Oncology Center of Excellence (OCE) is shifting the paradigm in cancer treatment development with Project FrontRunner— an initiative designed to encourage drug sponsors to develop, test, and seek approval of new cancer drugs for advanced or...
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Complex therapeutic development requires deep integration across clinical, regulatory, statistical, and operational functions. Whether optimizing dose, navigating regulatory pathways, or accelerating timelines, early and sustained collaboration is...
4 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
2 min read
Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies' interactions with global health authorities. Over the past two decades, eCTDs have evolved from a basic electronic substitute for paper to a robust, standardized...
2 min read
Medical writing plays an essential role in clinical development and regulatory approval. As scientific advancements grow more complex, well-structured documentation ensures the success of clinical trials, facilitates regulatory review, and accelerates...