Regulatory Affairs

Bettine Boltres presents at PDA Webinar

By Dr. Bettine Boltres

八月 24, 2020

Putting together a risk assessment for nitrosamines in your final drug product is an extensive undertaking. Many contributing factors need to be considered, such as the drug substance’s manufacturing process, excipients, buffers, water, production equipment and environment, transportation conditions, packaging, and more. Within this scope, primary packaging components, such as elastomeric closures, also could contribute nitrosamines or precursors.


By Lynn Yao

四月 13, 2020

The Standing Committee of the National People’s Congress in China passed the revised Drug Administration Law (Revised Law) on 26-Aug-19. Effective 1-Dec-19, it is the first overhaul since 2001.The Revised Law addresses the major issues in the pharmaceutical industry, demonstrating the government’s efforts in strengthening supervision to ensure drug safety.

Analytical Labs

By Lynn Yao

四月 03, 2020


By Your Side for Expertise

By T. Page McAndrew, Ph.D.

三月 04, 2020

West strives to be the world leader in the integrated containment and delivery of injectable medicines. The achievement of this goal relies on many factors, including a heightened awareness of industry and regulatory trends. By being able to anticipate these trends, West is better able to support its customers with the knowledge and services needed to ensure that drug products reach market on schedule.

By Your Side for Innovation

By Cindy Reiss-Clark

二月 19, 2020

For the healthcare industry, the last decade has brought profound changes that continue to shape how drugs are discovered, developed and commercialized. At West, we pride ourselves on helping customers manage change by continuously delivering innovative products and services. Our company keeps close tabs on industry trends to anticipate unmet need in the market and, when appropriate, to disrupt existing value networks.

Performance Testing

By Fran DeGrazio

一月 17, 2020

Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.  In part 2 of this blog series, some of the key takeaways will be discussed in more detail.  Q12 is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.