by Dipti Gulati | Nov 29, 2023 | Blog
An FDA warning letter (WL) is issued when the FDA finds significant problems with the quality, safety, or efficacy of drug products or a process, such as product development, manufacturing, or clinical trials. FDA warning letter remediation is a process of correcting...
by Dipti Gulati | Jul 12, 2023 | Blog
As the product moves from clinical development to commercial manufacturing, regulatory landscapes change. At the clinical development stage, safety and efficacy are not established, process knowledge is under development, stability data is being generated and the...
by Dipti Gulati | May 23, 2023 | Blog
A Journey from Basic cGMP to Optimized Quality Maturity The most recently proposed CDER QMM initiative has drawn curiosity and attention in the industry. The common questions are related to how it will be implemented, how it will impact companies, and what are the...
by Dipti Gulati | May 22, 2023 | Blog
From a regulatory standpoint, Sponsors are required to conduct a risk assessment or qualification audit during the CDMO selection process to understand if CDMO can maintain regulatory requirements and if there are any associated risks. Qualification audits help...
by Dipti Gulati | May 20, 2023 | Blog
Many drug manufacturers (owners) outsource different parts of manufacturing operations to bring products to market faster and at reduced costs. Outsourcing involves hiring a second party under a contract to perform the operational processes that are part of a...
