Regulatory Sciences
CMC Expectations During Drug Substance Transfer from Ex-US Manufacturers
Regulatory Drivers for US-based API Manufacturers Recent shifts in US tariff policies have introduced new pressure points in the global pharmaceutical supply chain, particularly for manufacturers...
Quality & Compliance
Dealing with API and Excipients in a Time of Tariffs
The US Government recently modified its policy to utilize tariffs to support the US economy. Pharmaceutical tariffs have been forecasted, causing many global organizations to investigate the...
Quality & Compliance
Tech Transfer Readiness: Big Responsibility, Greater Reward
So, you're thinking about Technology Transfers (i.e., TT or Tech Transfer)? This question may look familiar to you. That is because we asked this very question in the first installment of our Tech...
Quality & Compliance
Technology Transfer Projects: Assessing Need and Readiness
So, you're thinking about Technology Transfers (i.e., TT, Tech Transfer)? Who can blame you? There has been a significant amount of news recently regarding tariffs and the potential for bringing...
Quality & Compliance
Adapting Technology Transfer Strategies in Pharmaceutical Manufacturing Amidst New Tariff Regulations
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy causing many global organizations to investigate the consequences of the tariffs on their...
Quality & Compliance
Navigating the Impact of New Tariffs: Strategies for Success Amidst Recent Trade Policy Changes
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Significant changes have been announced causing many global organizations to investigate...
12 Critical Questions and Answers for a Successful Tech Transfer
12 Critical Questions and Answers for a Successful Tech Transfer Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time,...
Analytical Method Transfer Checklist
As you plan for an upcoming Tech Transfer, have you considered if you are appropriately prepared to conduct an analytical method transfer? With the simple analytical method transfer checklist...
Is Your Technical Transfer Process Aligned with Process Validation Requirements?
There has been a lot of discussion recently concerning process validation and technology transfer, including utilizing virtual technology transfers to quickly move products through the development...
How critical is the Technology Transfer phase of new drug development?
During the development phase of a new drug, great pains are taken to characterize the molecule and to run a myriad of laboratory and animal tests to determine the product attributes, toxicology...