Resources

Since the Pandemic became global in 2020, the FDA has been requesting documents from firms in advance of or in lieu of an inspection. This authority comes from the Federal...

Leveraging Process Analytical Technology for CMC Introduction In the evolving field of pharmaceutical development, the implementation of Process Analytical Technology (PAT) for manufacturing is an essential competitive advantage. PAT offers...

The world has changed in many ways since the outbreak of the global COVID-19 pandemic. Regulators are taking advantage of technology to institute greater social distancing, limiting contact between people...

Cell and Gene Therapies also known as (ETMPs) have continued to evolve in recent years. Over the last 15 years the industry and regulatory bodies have continued to learn more...

Click now to learn from Sue Schniepp, Distinguished Fellow at Regulatory Compliance Associates, as she describes microbial process design and how your team can improve contamination control. Human microbes live...

During times of crisis — such as the global pandemic — keeping supply chains moving becomes even more important. Issues with supply chains can lead to critical shortages of items...