general regulatory

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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

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...

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...

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...

Regulatory Sciences

How to Successfully Prepare for the HTAR Implementation in the EU

Health technology developers (HTD) planning submission of a centralized Market Authorization Application (MAA) to the European Medicines Agency (EMA) should being preparing today for the...

Regulatory Sciences

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...

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Regulatory Sciences

Mandatory HTAR Implementation in the EU: Part 2

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking...

Ensure Compliance with EU HTA Regulation (HTAR) Guidelines & Implementation

Regulatory Sciences

Mandatory EU HTAR Implementation: Part 1

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health...

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