Blog | Veristat, The Science-First CRO

2 min read

Strengthening Opportunities for Growth in the European Region

3 min read

Regulatory Guidance Monthly Review - June 2023

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

How does Real-World Evidence Impact Medicinal Product Development in Europe?

Explore the growing role of Real-World Evidence (RWE) in the regulatory decision-making process for medicinal products in Europe. Learn how RWE is reshaping the development landscape, its potential benefits, and the challenges associated with its...

5 min read

Regulatory Guidance Monthly Review - May 2023

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...

4 min read

Regulatory Guidance Monthly Review - April 2023

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...

4 min read

Regulatory Guidance Monthly Review - March 2023

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...

Bold Thinking that Delivers Results for RNA Therapies

Current advances in RNA-based therapies hold substantial promise in treating and preventing many human diseases and disorders through curing the disease, rather than treating the symptomology like traditional therapeutics.

4 min read

Regulatory Guidance Monthly Review - February 2023

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

European Medicines and Medical Devices: Future Trends

Based on an online seminar presentation made in collaboration with TOPRA and Veristat, this article dives into the future of the European medicines and medical devices industry and the changes in legislation that are being prompted by the evolving...

1 min read

Podcast: Orphan Drug Designations and Orphan Subsets

Sponsors developing drugs or biologics intended to prevent, diagnose, or treat a rare disease or condition should consider applying for the Orphan Drug Designation (ODD) program with the FDA. The FDA’s Orphan Drug Designation program is meant to...