regulatory sciences

Clinical Research Solutions

FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements

Implementing the eSTAR Format The eSTAR template is a positive step for both CDRH and medical device Sponsors; but, as with any new tool, there are challenges to utilizing the template. Sponsors need...

Hand with pen preparing FDA regulatory documents

Clinical Research Solutions

Regulatory Chemistry, Manufacturing, and Controls (CMC): What to Expect During Drug Development

The key to successful drug development in the US is directional and focused navigation of FDA’s Investigational New Drug (IND) process. The Chemistry, Manufacturing, and Controls (CMC) section is a...

Clinical Research Solutions

FDA Animal Rule: Overview & Impact on Drug Development

What is the Animal Rule? The Animal Rule, a regulation set by the US Food and Drug Administration (FDA), applies to the development and testing of drugs and biological products intended to reduce or...

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Clinical Research Solutions

The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 2

Change in the Submission of the Summary Notification Information Format The Summary Notification Information Format Form As of January 31, 2023, Sponsors are required to submit a Clinical Trial...

Clinical Research Solutions

The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 1

The Benefit of the Common Application Form for GMO Applications GMO Application Not Included in Clinical Trial Regulation With the transition period for the Clinical Trial Regulation No 536/2014...

Clinical Research Solutions

Highlights from FDA's Analytical Test Method Validation Guidance

Recently, the FDA updated a long-standing, decades old guidance on analytical test method validation based on revisions of the ICH Q2(R2) guidelines. Traditional test method validation requirements...

Clinical Research Solutions

MLR Submission Content: Setting Yourself up for a Successful PRC Review

Having a highly efficient well-oiled Promotional Review Committee (PRC) machine is not just about having rock star reviewers and effective best practices in place. Although those are both critical...

Clinical Research Solutions

What to Expect During the NDA Review Process

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

Clinical Research Solutions

Beyond the Trifecta: Best Practices for a Successful Promotional Review Committee (PRC) Process

To reduce frustration within a promotional review committee (PRC), the PRC must be a well-oiled machine firing on all cylinders and working at optimum capacity. How does a PRC achieve this? By...

Clinical Research Solutions

The Trifecta of Promotional Review: What is a PRC & What do They Do?

The mystique of PRC unveiled – what is it and why you need it to assure successful promotional review. You have received approval from the regulators. You have a dynamic sales force in place. They...

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