In this article, we overview how the U.S. pharmaceutical regulations evolved in 2025, and what companies can do to adapt to a regulatory landscape in a constant state of flux.

Transferring analytical methods is key to ensure that the receiving laboratory produces the same results as the transferring laboratory. This article outlines several best practices that aid in creating methods that are replicable and fulfill regulatory requirements.

A Post-Approval Change Management Protocol (known as Comparability Protocol in the United States) helps to develop streamlined submissions, achieve a faster time to market, and ensure a continuous supply of safe medicines to patients. This article lists some practices to design protocols that promote regulatory compliance while also helping to avoid delays.

Quality performance indicators (QPIs) are a tool that pharmaceutical companies employ to track excellence, regulatory compliance, and efficiency across products and processes. The value of QPIs has been recognized by the U.S. Food and Drug Administration (FDA), which encourages their use as they promote continuous improvement. This article describes three best practices organisations can implement to establish QPIs that align with current good manufacturing practices (CGMP).

A new U.S. policy could tie the price of drugs in the U.S. market to the lowest possible price paid by countries that are members of the Organisation for Economic Co-operation and Development (OECD). 

In this article, we define some best practices for creating Standard Operating Procedures (SOPs) that can be adapted based on the specific needs and context of pharmaceutical manufacturers.