|The most experienced and trusted provider of Biosafety solutions, the WIRB-Copernicus Group® (WCG) has evaluated over 150 human gene transfer protocols to date – more than any organization outside of the Food and Drug Administration (FDA) and the National Institute of Health (NIH). We also maintain a global presence, operating Institutional Biosafety Committees (IBCs) in the United States and Canada, as well as in eight countries in Africa, South America, Central America, the Caribbean, and Europe. WCG Biosafety’s consulting division has led laboratory and biosafety projects in more than 50 countries over three decades, assisting government, academic and private institutions in maintaining the highest level of safety, security and compliance.
|The demands for biological safety are – and will continue to be – dynamic. Through their trusted partnership with WCG, our clients achieve the safe and successful management of research involving rDNA and other potentially hazardous biological vectors.
Our Services Include:
- IBC Services
- IBC review and assessment services
- Transitional support (internal IBC to administration to external IBC administration)
- Accreditation support (for the use of newly-approved biologic and gene therapy products)
- Clinical Trial Protocol Development for Recombinant Materials (subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids)
- Biosafety Consulting Services
- Biosafety Program Assessments (reviews for regulatory compliance and best practices, gap analyses and corrective action)
- Biosafety Program Management (temporary staffing, outsourced program management)
- Biocontainment Laboratory Verification (initial or re-verification of BSL-2, 3 and 4 laboratories against CDC/NIH/USDA guidance, and support of lab design efforts)
- Biosafety Training (Biosafety/Biosecurity, IBC and PI, Select Agents, Bloodborne Pathogens, and customized topics)