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...
1 min read
In today's world where digital transformation is reshaping industries, even the pharmaceutical sector is not immune to regulatory compliance. The FDA approval process has become significantly streamlined with the introduction of electronic record...
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
Veristat, in partnership with TOPRA, recently hosted an insightful webinar titled "Future Trends on European Regulations on Medicines." This webinar provided valuable updates on the new Pharmaceutical Strategy for Europe and its impact on the regulatory...
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
Veristat and TOPRA recently hosted an informative webinar on the topic of the impact of new EU regulations on the development of medical devices and drug combination products. The European Commission's adoption of Regulation (EU)
1 min read
It is crucial for biosimilar developers to engage early and often with FDA to ensure the health authority is well-informed and supports your planned development path. Regulatory meetings and interactions provide sponsors the opportunity to receive...