Active Pharmaceutical Ingredient Api

Technology transfer documents floating

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...

A Robotic arm placing medicine bottles on conveyor belt in manufacturing facility.

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...

A Roadmap for Clinical Trials: QP Certification of IMP

Please note that updates to regulations may have been implemented since the publication of this article. The 20th century was the century of many scientific discoveries in the field of medicine....

Supplier Qualification in the Pharmaceutical Supply Chain

The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...