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Regulatory Submissions (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...

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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...

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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...

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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...

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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...
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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...

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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...

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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...

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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...

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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...

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