Pharmacovigilance
EU Clinical Trials Regulation: Time Is Running Out, Are You Ready?
On January 31, 2022, the EU Clinical Trials Regulation 536/2014 (CTR) came into force with a transition period of three years. Now, as that transition period comes to a close, the process and need...
Quality & Compliance
Navigating the Nordic Pharmaceutical Landscape: Key Considerations for a Successful Launch
The Nordic region, renowned for its world-class healthcare, presents unique opportunities and challenges for pharmaceutical companies. Understanding the Nordic pharmaceutical landscape is crucial for...
Regulatory Sciences
How to Create Successful Pricing and Reimbursement of your Pharmaceutical Product in the Nordics
Our Nordic region features world-class healthcare. Understanding the Nordic healthcare and market access landscape is crucial for successful pricing and reimbursement of your pharmaceutical product....
Regulatory Sciences
How a Strong Regulatory Strategy Supports Your Product’s Success
One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. Traditionally, the need...
Regulatory Sciences
FDA Drug Labeling Requirements & Regulations: What’s in Your Label?
Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters? A drug’s label...
Regulatory Sciences
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...
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...
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...
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...
Quality & Compliance
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
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...
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...
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...
Regulatory Sciences
EU Pharmaceutical Legislation Reform: Where Are We Now?
On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...