Biological drugs, or biologics, are a regulatory category encompassing living organisms and substances derived from them. Common biologics include blood products, cells, gene therapies, tissues, and vaccines. In some cases, probiotics may be classified as biologics. Regulated as pharmaceutical drugs in Canada and the U.S., biologics require pre-market approval before they can be sold.

Biologics pose unique regulatory and scientific challenges compared to conventional pharmaceuticals due to their complex and varied composition. Scientific evidence, including clinical trials, are used to support product safety, efficacy, and quality. Biologics are also susceptible to microbial contamination and stability concerns, making analytical and bioanalytical testing essential to ensure product quality.

Learn how we can help you develop and launch a biologic that meets research and compliance requirements.