Quality & Regulatory
Quality & Regulatory Services
BioPharm Process Associates can create a global CMC-regulatory strategy, identifying the essential regulatory requirements as well as outlining all product quality and process performance parameters within your specified timelines and budget.
We have first-hand experience with the necessary quality and regulatory requirements for your products, including both the set-up and operation of complete quality systems. We have coordinated and written components of numerous regulatory filings in both the US and Europe. We have validated pharmaceutical facilities, utility systems, process equipment and manufacturing processes, so we can save you time and prevent having to repeat critical regulatory steps.