A Proactive Guide to Documentation and Digital Strategy. In the highly scrutinized biopharma industry, regulatory compliance and meticulous documentation are the bedrock of success. For…
Quality by Design (QbD) principles have been incorporated into regulatory guidelines for over two decades, so regulated life science companies are familiar with the requirements…
Expedited Approval Pathways Increase Risk and Burden on CMC and Manufacturing: risk reduction strategies include earned value analysis and partnering. As discussed in a recent…
At The Windshire Group, Chemistry Manufacturing and Controls (CMC) includes allied activities throughout the product lifecycle... While I believe the term, Chemistry, Manufacturing and Controls (CMC) …