Why It's Smarter to Play the Long Game When Planning Your FDA Submission
The drug development process is long and expensive. You are doing yourself and your product a huge advantage if you enter and go through the process with a well-researched plan. When planning your...
6 Ways to Increase the Value of Your Cell and Gene Therapy or ATMP Development
As the field of modern medicine is changing, so should the development strategies of these new therapies such as cell and gene therapy (CAGT) products, also known as advanced therapy medicinal...
Quality & Compliance
How to Ensure Your Device, Software, and Drug Are All Ready for a Pre-Approval Inspection
When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a...
EMA Vaccine Applications for COVID-19 Explained
Preventive vaccines are a special kind of medicinal product, as they are administered before a disease instead of during. You are probably familiar with preventive vaccines from your own or your...
Regulatory Sciences
What You Need to Know About the ICH
The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices....
Clinical Research Solutions
Virtual GCP Auditing: Your Questions Answered!
How quickly the auditing landscape has changed! Less than one year ago if ProPharma were asked to perform a clinical audit on your firm’s behalf, we would reply with "when, what, and where?" Today...
Quality & Compliance
7 “Aha Moments” in Data Integrity
If you are interested in data integrity, you likely have read many articles about the topic. This blog delivers 7 new insights to data integrity, looking at it from different angles. Seven ways to...
Clinical Research Solutions
4 Hidden Obstacles to Clinical Trial Success
It's no wonder scientists begin clinical trials with great excitement: combine promising discoveries with the best test sites, scientists, and as many qualified, willing patients as possible, and off...
Regulatory Sciences
Improving Cost Efficiency, Speed, and Completeness of Generic Applications
An abbreviated new drug application (ANDA) is a “streamlined” marketing application that is submitted to the FDA for review containing information and data about a generic drug product. Once...
Clinical Research Solutions
The Key to a Stable Supply of Medicines
The COVID-19 pandemic revealed a structural weakness in many products' supply chains. In terms of supply of pharmaceutical products, supply shocks were not mitigated when intermediates or production...
Clinical Research Solutions
Lean Principles: A Life Sciences Overview
Today, with the FDA endorsing fewer new treatments, life sciences companies are pressured to develop better therapies while also struggling to control costs and retain their star employees. And while...
Quality & Compliance
6 Tips for Evaluating Your CMO’s PAI Readiness
The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...
Quality & Compliance
Conducting a PAI Mock Inspection: How to Execute and Evaluate Your Findings
Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...
3 Factors to Consider in the Manufacturing Phase for Drug Device Combination Products
Combination products represent an important and growing category of therapeutic and diagnostic products. They come in several configurations and can be composed of any combination of a drug and a...
Clinical Research Solutions
Pediatric Labeling Best Practices
A large percentage of drugs are used off-label in pediatric patients. Unfortunately, when a patient uses a drug off-label, the drug is being used without FDA approval, which might result in...
8 Common QMS Mistakes to Avoid
Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS)...