ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
What is a Clinical Evaluation Report (CER)?
If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term ‘CER’ or Clinical Evaluation Report. However, do you really know what a CER is and how it evolved into the modern...
Staying GMP Compliant: A Consultant's Guide to Compliance Bliss
Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...
Ensuring Quality in Clinical-Phase Drug Manufacturing: A Comprehensive Guide
Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry, ensuring that every aspect of drug manufacturing...
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...
Risks to Consider when Implementing AI Technology in Medical Information
AI is a highly praised tool to implement across industries and service lines and Medical Information (MI) is no exception. In Medical Information, AI is embedded in a workflow for patients and...
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...
Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights
As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a...
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...
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...
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...
Understanding Statistical Intervals: Part 2 - Prediction Intervals
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
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...