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....
Clinical Research Solutions
PMA Post-Approval Study Considerations
In the US, post-market clinical studies are not required of every medical device manufacturer. However, the Food and Drug Administration (FDA) does have the authority to order post-market...
Medical Information
Leveraging Offshore Excellence: Enhancing Medical Information Services Through Contact Centers in India & the Philippines
As the pharmaceutical landscape in the Japan and Asia-Pacific (JAPAC) region continues to evolve, the demand for efficient, high-quality medical information (MI) services has never been greater. Our...
Clinical Research Solutions
The Care and Feeding of FDA PMAs: Mastering Premarket Approval
Congratulations, FDA has approved your PMA! Now what? Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's...
Quality & Compliance
Navigating EU GMP Compliance: A Consultant's Guide to Smooth Sailing
Hello, fellow pharma enthusiasts! In the fast-paced world of pharmaceuticals, ensuring Good Manufacturing Practice (GMP) compliance is essential to maintaining product quality and safety. The...
Quality & Compliance
Navigating the Regulatory Maze: Clinical Data for Medical Device Approval
In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory...
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...
Pharmacovigilance
Common Challenges in Signal Detection in Pharmacovigilance and How to Overcome Them
In pharmacovigilance, recognizing and responding to safety signals quickly can be crucial for patient safety. A "signal" in pharmacovigilance refers to a hypothesis, supported by evidence, of a new...
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...