ARTICLES BY BIKASH CHATTERJEE
Ensuring Quality In Ventilator Production Scale-Up For COVID-19
Chief Editor Louis Garguilo asked Outsourced Pharma Advisory Board member and COO/CSO of Pharmatech Associates, Inc., Bikash Chatterjee, to update our readers periodically on what he is seeing and experiencing during this coronavirus pandemic. This is his first update.
Best Practices For Measuring System Quality For Drug-Device Combination Products
Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.
Managing QMS Disparities Between Drugs And Devices For Combination Products
Combination products represent a remarkable opportunity as one of the most dynamic segments in the life sciences and are projected to grow to $115 billion by 2019.