3 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
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...
2 min read
As the industry continues to adopt a patient-centric approach, the use of real-world data is becoming increasingly essential in informing drug development and regulatory decision-making. To develop patient-focused strategies, researchers must gain a...
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...
1 min read
Clinical trials require meticulous planning and strategic guidance for success. In this case study, Veristat's expertise was instrumental in transforming a clinical-stage biotech company's maiden Phase I trial for an immuno-oncology antibody.
Initially...
4 min read
Veristat’s Science Advisory Board met on 14 March 2023 to discuss Executing Patient-Focused Drug Development (PFDD), with a focus on the application in rare diseases.
Patient health and wellness extend beyond biology and symptoms of disease, encompassing...
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
In the world of biotechnology, where groundbreaking discoveries have the potential to change lives, adaptability and flexibility are paramount. Clinical operations can be a complex web of challenges, especially when dealing with rare diseases and gene...
3 min read
When seeking guidance from the FDA, EMA, or other regulatory agencies regarding the inclusion of a Natural History study in your clinical development program, it is crucial to initiate early and frequent discussions with the regulatory authority to...
2 min read
Biotherapeutic development is challenging due to evolving industry standards and increasing regulatory scrutiny. A roadmap for success is essential. Watch Veristat's on-demand webinar on Regulatory CMC Excellence in Biotherapeutics, including key...