View in browser

The Rapid Pace of Regulatory Change

Successfully keeping up with evolving regulatory requirements can be challenging, especially for those organizations that conduct clinical studies in North America and Europe. Untimely or uninformed decisions related to regulatory compliance and reporting can throw a trial off track.

This month’s edition of Voyager provides insights on the value a Veristat partnership delivers to overcome the regulatory hurdles that arise during clinical development, product approval and post-marketing surveillance. Rely on us to help pave an efficient pathway to approval.

Expanding your Clinical Trial into the US: How and When to Submit your IND for non-US Sponsors

Live TOPRA Webinar | 17 June 2021

Register for this free webinar

Submitting an IND application to the FDA is a key step in developing a new drug or biologic.

Attend our live webinar hosted by TOPRA and hear from Veristat regulatory experts on how, why, and when to expand your clinical trial program into the US, including similarities and differences between IND and CTA.

Register now

Brief: Successful Preparation Strategies for NDA/MAA Marketing Applications

No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same.

Read our Brief and discover how to manage common operational complexities and overcome data analysis challenges.

Read the brief

At-A-Glance: Ensuring Drug Safety across All Phases of Development and Post-Approval 

While it is critical to ensure patient safety throughout the clinical trial, it doesn’t end there.

Learn how our specialized experience helped us deliver a 100% score on GVP inspections for Sponsors with no major observations received over the past 5 years. 

Learn more

Case Study: Writing Marketing Applications Simultaneously with Accelerated Timelines

The writing process for any Marketing Application is complex, but even more so when writing an NDA, NDS and MAA at the same time.

Learn how our medical writing team worked closely with trial co-sponsors to write three marketing submissions, submitted within 6 weeks of one another as the product received Orphan Drug Designation in multiple regions.

Read the case study

Helping to Bring New Hope to Children Suffering from MoCD Type A

Rare disease therapies often need to take more complex clinical and regulatory routes.

Learn how Veristat’s biostatisticians, programmers, and medical writers collaborated with Origin Biosciences to support the New Drug Application (NDA) for Nulibry.

Learn more

Did You Know?

Veristat supported Marketing Applications for 10% of all FDA novel drug approvals in 2020. Learn more

Veristat’s regulatory experts possess extensive experience crafting strategies across every phase of a clinical study.

Explore our key related services:

CONTACT US

VERISTAT.COM