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The regulatory landscape for cell and gene therapies (CGTs) is shifting fast. From increased scrutiny on Chemistry, Manufacturing, and Controls (CMC) to operational challenges at the U.S. Food and Drug Administration (FDA), sponsors must be prepared to...
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The decision to partner with a Clinical Research Organization (CRO) is never taken lightly—especially in oncology. With high complexity, accelerated timelines, and evolving regulatory expectations, the stakes in oncology drug development are uniquely...
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The development of innovative oncology therapies has evolved dramatically, moving beyond traditional chemotherapies to include immunotherapies, targeted agents, radiotherapies, and cell and gene therapies. As these new modalities emerge, the limitations...
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Learn how Veristat’s multidisciplinary team helped sponsors navigate the complexities of global regulatory submissions, achieving early and successful outcomes.
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In partnership with Clinical Leader, Veristat consulting, regulatory, and clinical experts gave a live webinar outlining how to better advance new cancer therapies in alignment with FDA’s Project FrontRunner. The webinar covered the following:
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Are you interested in learning about the latest FDA initiative to accelerate the development of new cancer treatments? Veristat's informative webinar "Advancing Development of New Oncology Therapies, aligning with FDA's Project FrontRunner" is an...
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Learn how Veristat's expert medical writing team supported a global specialty pharmaceutical company with 130+ projects for rare disease treatments. Our longstanding thirteen-year relationship, built on trust and quality, continues to thrive as we help...
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At Veristat, we pride ourselves on transforming challenges into triumphs, particularly in the complex pharmaceutical and biotech development world. Our recent collaboration with a small-sized biotech company targeting cancers of the reproductive system...
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In 2022, the FDA’s Center for Drug Evaluation and Research (CDER) launched the Accelerating Rare disease Cures (ARC) Program to help bridge the gap between the urgent needs of patients and the complexities of rare disease drug development.
ARC’s mission...
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In the intricate world of pharmaceuticals and biotechnology, every step of drug development is meticulously scrutinized by regulatory bodies. For small to medium-sized companies in the field, the journey can be fraught with challenges, especially in...