October 2025 | Mastering Regulatory Compliance and Documentation
In the biopharma industry, regulatory compliance and meticulous documentation are the bedrock of success. Especially as it relates to Chemistry Manufacturing and Controls (CMC). Small…
January 2025 | Implementing Continued Process Verification (CPV): Smart Business and a Regulatory Expectation
CPV is a method used in pharmaceutical manufacturing to ensure consistent product quality and regulatory compliance. It involves the continuous monitoring of critical process parameters…
December 2024
CMC Due Diligence Best Practices Due diligence is crucial in the pharmaceutical industry for mitigating risks and ensuring success, especially during mergers, acquisitions, and licensing…
November 2024
CMC Due Diligence Common Stumbling Blocks Conducting thorough CMC due diligence in the pharmaceutical industry is essential to avoid pitfalls that can jeopardize the success of…
September 2024 | Avoiding Pitfalls in CMC: The Power of ‘Measure Twice, Cut Once
Running afoul of the adage, “measure twice, cut once” can upend a construction project. But what it can do to a CMC (Chemistry, Manufacturing, and…
August 2024
In this fast paced and dynamic life sciences industry, it’s worth remembering regulatory compliance is a journey, not a destination. It requires a proactive approach to adapt…