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.
Explore our regulatory and clinical services for biologics:
- Product Development Strategy
- Clinical Trials
- Drug Establishment Licensing
- New Drug Submissions (NDS) and New Drug Applications (NDA)
- Abbreviated New Drug Submissions (ANDS) and Abbreviated New Drug Applications (ANDA)
- Clinical Project Management
- Clinical Trial Design
- Regulatory Affairs
- Early Clinical Development
- Phase II/III Clinical Trials
- Phase IV Clinical Trials
- Rescue Studies
- Feasibility Studies
- Site Selection and Management
- Medical Affairs and Pharmacovigilance
- Data Management
- Functional Services
- On-Site Clinical Trial Services
Product testing services for pharmaceuticals include:
Learn how we can help you develop and launch a biologic that meets research and compliance requirements.