Clinical Research Solutions
4 Common Bottlenecks to Avoid in the Development of Biopharmaceuticals
If you are involved in early development of biopharmaceuticals, have you ever experienced serious delays because of problems arising from tech transfer, from the first pilot scale batches not meeting...
Clinical Research Solutions
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...
Clinical Research Solutions
Understanding EMA and FDA Regulations on Nitrosamine Control
On September 26, 2019, the European Medicines Agency (EMA) released an advice to Marketing Authorization Holders (MAH) of human medicines to review their drug products on possible presence of...
Clinical Research Solutions
Are Your Compliance Obligations Being Properly Upheld? Avoid This Common Outsourcing Mistake!
Over the past several decades, the traditional approach to drug development and manufacturing has expanded to include the outsourcing of a range of functions from product development and testing, to...
Clinical Research Solutions
Pharmaceutical Tech Transfer Best Practices - A Quality Perspective
About 15 years ago, I was a project management director responsible for moving monoclonal antibodies (MABs) from Phase III clinical to commercial manufacturing. I had the distinct pleasure of working...
Clinical Research Solutions
Unlocking Success with Clinical Trial Safety Monitoring During a Pandemic
Earlier this year I wrote to you about US FDA March 2020 issuance of a new guidance for industry, Investigators, and Institutional Review Boards regarding the conduct of clinical trials during the...
Clinical Research Solutions
Uncover Opportunities for Improvement with an Annual Product Review
The Annual Product Review (APR), also known as the Annual Product Quality Review (APQR), is required for marketed products in an FDA-regulated environment. You may ask, “Why would I want to perform...
Clinical Research Solutions
EudraLex Volume 4, Annex 1 Update: What You Need to Know
EudraLex Volume 4, Annex 1 provides guidance for the manufacturing of sterile medicinal products that are intended for the European market. It has been updated several times, with the latest revision...
Clinical Research Solutions
How to Prepare for Laboratory Partner Selection during CBD Product Development
The interest in developing consumer products or therapies derived from Cannabis or CBD is continuously growing. As these new products come to market, there is increasing need to comply with...
Clinical Research Solutions
How Many Observations are Hiding in Your Quality System?
Reflecting on 2020, we have become accustomed to the global shift into a world of virtual, remote, restricted, and paused. One no longer flinches when hearing that something has been modified,...