How to Ensure Your Workforce is GMP Compliant
As the world tries to get back to some semblance of normalcy after the coronavirus pandemic, pharmaceutical, biotech and med device companies are anticipating the day when the FDA returns to normal...
How to Prepare for the Three Type B Meetings with the FDA
The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND meeting, the second is the End of Phase 2...
How to Understand and Avoid Common Phase 3 Failure Points
By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least...
The Unique Challenges of Gaining Approval for Drug-Device Combos
A combination product is composed of any combination of a drug and a device; a biological product and a device, a drug and a biological product, or a drug, device, and a biological product. Consider...
Analytical Methods for the Investigation of Carcinogenic Nitrosamines in APIs and Drug Products
Since September 26, 2019, all EU Marketing Authorization Holders (MAHs) of medicines for human use are facing what might be regarded as a new requirement: review their drug products on the possible...
Why is Process Optimization so Important in Cell and Gene Therapy Product Development?
A recent survey of experts from 145 cell and gene therapy (CAGT) companies revealed the ability to appropriately optimize the manufacturing process as their top concern. Red flags have been raised...
2020 in Review: Reflecting on the Biggest Events & Breakthroughs
2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with...
Improve Quality Using an Organizational Maturity Model
If this is your first introduction to an Organizational Maturity Model (OMM), you may have a few questions. What is an OMM? What are some common obstacles I might face when implementing an OMM? How...
3 Basic Data Integrity Principles to Protect Value and Drive Success for Cell and Gene Therapy/ATMP Development
Cell and Gene Therapy (CGT)/Advanced Therapy Medicinal Products (ATMPs) have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to the...
Clinical Research Solutions
Pre-Approval Inspection (PAI): What it is and How to Prepare
What is a Pre-Approval Inspection (PAI)? A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug...