Regulatory Sciences
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
What is the FSP Model in Clinical Research?
The term Functional Service Provider (FSP) concept is highly regarded in the field of clinical research. With drug discovery and clinical trials becoming more complex, pharmaceutical firms and...
Pharmacovigilance
Meet the Expert: Tariq Khan
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
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...
Clinical Research Solutions
Meet the Expert: Terri Levine
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
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...
Regulatory Sciences
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...
Pharmacovigilance
Meet the Expert: Susanna Heinonen
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
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...
Regulatory Sciences
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...