Clinical Research Solutions
What is Product Lifecycle Management and Why is it Critical for Success?
Product Lifecycle Management (PLM) is the process of managing a product from conception through end of of life (EOL), and clearly includes conception (design and development) and commercialization....
Clinical Research Solutions
How to Select the “Right” CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company’s needs. Every company knows, timing is critical to success. But...
Clinical Research Solutions
Prepare for Your Next Audit: A 5-Point GMP Checklist
Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so...
Quality & Compliance
What is Software Quality Assurance (SQA) and Do You Need it For Your Business?
If your only method of quality assurance is software testing, you're wasting valuable time and resources. Software Quality Assurance (SQA) is integrated into your software development life cycle to...
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
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
6 Tips to Prepare Your Medical Cannabis Facility for Inspection
You may be considering building a new facility for growing, harvesting, and processing medical cannabis, or perhaps you have an existing facility and want to export to the European Union. What should...
Quality & Compliance
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
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
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...