biologics manufacturing
Biologics Manufacturing Operations
CeBio has a reputation for demonstrated excellence in technical expertise, consultation services for Biologics (Vaccines), Pharmaceuticals, and Cell and Gene Therapy, and CDMOs.
Quality and Compliance
CeBio offers a complete range of Quality and Compliance Services to meet the regulatory requirements of the FDA, Health Canada, MHRA, EMA, and other regulatory bodies, and to ensure quality products are delivered to the global market.
CeBio team includes dedicated industry experts with solid knowledge base, decades of industry experience . We provide customized Quality and Compliances services to clients to reduce compliance risk.
Computer Systems Validation
The FDA, Health Canada, MHRA, EMA, and other regulatory bodies require regulated companies to perform computer systems validation (CSV) on any software system used to collect, store, analyze, report or transfer data in the place of paper data in cGMP, cGLP, and cGCP environments.
CeBio consultants understand the process, science, infrastructure, and instrumentation as well as the regulatory agency audit processes. We provide customized validation services to clients to reduce validation risk.
Training
At CeBio, we are current with the standards and requirements of regulating bodies (FDA, Health Canada, etc. ). We provide training services in the following areas:
• Good Manufacturing Practices
• Good Laboratory Practices
• Good Documentation Practices
• Good Clinical Practices
• Qualification and Validation
• Auditing & Compliance Management
• Cleanroom Behaviour and Contamination Control Best Practices
• Training Materials
• Credit courses