Regulatory Sciences
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...
Regulatory Sciences
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...
Regulatory Sciences
FDA Releases Final ICH M13A Guidance Document
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...
Regulatory Sciences
Act Now! Navigating the Windsor Framework in the UK
A New Era for Pharmaceutical Development and Licensing in the UK The Windsor Framework, set to be implemented from January 1, 2025, marks a significant shift in the regulatory landscape for...
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...
Regulatory Sciences
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...
Quality & Compliance
15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?
Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific...