Blog | Veristat, The Science-First CRO

Gain the latest insights and trends in clinical trials, patient recruitment, data analysis, adaptive design, regulatory submissions and approvals.

Sign Up Today

Regulatory Consulting (2)

2 min read

Unleashing Flexibility in a Rare Disease Gene Therapy Clinical Trial

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...

READ MORE

1 min read

Unlock the Secrets of Effective SD File Preparation for FDA Submissions

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...

READ MORE

4 min read

Regulatory Guidance Monthly Review - August 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...

READ MORE

1 min read

Exploring Future Trends on European Regulations: A Webinar by Veristat and TOPRA

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...

READ MORE

4 min read

Regulatory Guidance Monthly Review - July 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...

READ MORE

1 min read

Unlocking Insights: The Impact of New Medical Device EU Regulation (MDR)

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)

READ MORE

2 min read

Strengthening Opportunities for Growth in the European Region

With the recent changes in clinical trial regulations and the growth of clinical trials in Europe, Veristat continues to build its footprint in the European region. Veristat’s VP of Europe, Montserrat Barcélo Riera, recently spoke to Annelot Huijgen of...
READ MORE

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...

READ MORE

The Influence of MDR’s Article 117 in the Marketing of Combination Products

The European Union Medical Device Regulation’s (MDR) Article 117 brings improved patient safety measures with new implications for manufacturers, as they must fulfill a significant set of additional requirements.

READ MORE

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...

READ MORE