Clinical Research Solutions
How to Manage the Risk of Elemental Impurities with ICH Q3D
How to Manage the Risk of Elemental Impurities with ICH Q3D: The mission of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to ensure...
Top Challenges in Managing Your Product Quality Complaint Lifecycle
The Product Quality Complaint program is an essential tool in a company’s quality and compliance toolkit, not only for reducing patient risk and enhancing customer satisfaction, but because it...
Clinical Research Solutions
The Importance of Using a Multidisciplinary Approach in Early-Stage Development for Cell and Gene Therapy Products
Implementing a multidisciplinary approach in cell and gene therapy product development is critical to the product’s eventual success or failure. In our experience, the consequence of not effectively...
Phase Appropriate Controls and GMPs in Cell and Gene Therapy
How much is too little versus too much when developing quality systems and controls for investigational cell and gene therapies? Because these therapies are being administered to patients during all...
Digital Transformation
Research and Development is More Important Than You Think
Research and development is a key component in the successful discovery and development of new drugs and medical devices entering the market. It’s also an area of big business, with investments in...
Clinical Research Solutions
Brexit: New Regulatory Opportunities in the United Kingdom
As the dust settles on the final Brexit deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is forging new opportunities to innovate, increasing its efficiency, and...
Clinical Research Solutions
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...
Clinical Research Solutions
12 Critical Questions and Answers for a Successful Tech Transfer
12 Critical Questions and Answers for a Successful Tech Transfer Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time,...
Clinical Research Solutions
Meet the Expert: Eric Good, PhD
ProPharma has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
Top 9 Failure Points During Nonclinical Development
The process of drug development involves clinical and nonclinical studies. Nonclinical studies are considered crucial for understanding the safety of new drugs. Before testing a drug in people,...
Quality & Compliance
Analytical Method Transfer Checklist
As you plan for an upcoming Tech Transfer, have you considered if you are appropriately prepared to conduct an analytical method transfer? With the simple analytical method transfer checklist...
Clinical Research Solutions
Stability Testing of New Drug Substances and Products
The stability of a drug substance or product is a critical attribute for all pharmaceutical products. As such, stability testing is required throughout the drug development phase as well as...
Data Integrity in Clinical Research: Audit Trail Review as a Key Tool
Data Integrity in Clinical Research: Audit Trail Review as a Key Tool A recent position paper from the eClinical Forum and the Society for Clinical Data Management highlighted the value of audit...
Clinical Research Solutions
The Truth Can Hurt - But Hearing It at the Right Time Can Save Time and Money
No one has an ugly baby. At least, no one thinks their baby is ugly. Every new parent thinks their baby is the most beautiful baby of all time. But the unfortunate fact is that there are ugly babies....
Clinical Research Solutions
Is Your Technical Transfer Process Aligned with Process Validation Requirements?
There has been a lot of discussion recently concerning process validation and technology transfer, including utilizing virtual technology transfers to quickly move products through the development...
Clinical Research Solutions
5 Tips for Achieving Regulatory Success in 2021
As we begin to wrap up the year and look ahead to 2021, it is critical to prepare your team for what is coming in the weeks and months that lay ahead. Preparation and preparedness are key to ensuring...