How ICH Q12 Aims To Cut Post-Approval Regulatory Submissions
 

Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

Regulatory Changes Address China’s Bioprocessing "Black Eye"
 

This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays. Understanding what efforts are being made to facilitate market entry is critical for any company considering expansion into this challenging but flourishing area of the pharmaceutical industry.

At-Risk Countries Benefit From Accelerated Vaccine Production
 

Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

Biopharma: How To Win In Emerging Markets
 

Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?

Regulatory Expectations For Biosimilars Development In India
 

As India’s biosimilar market moves toward a promising future, it is important to gain an overview of the current regulatory and clinical expectations in India for biosimilar products.

BeiGene's Modular Facility Eases China Capacity Problem
 

Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries. A commercial-stage biotechnology company with a large-scale biological manufacturing facility currently under construction in Guangzhou, China, can attest to these challenges.