Regulatory support

Regulations in biosafety are widespread and cover a number of particular domains, such as the workers protection, contained use and biocontainment, environmental release of GMOs, waste management, GMOs in food products, emergency planning, biosecurity, transport, import and export of biological material... Besides the main legislation, some more specific regulations such as the Cartagena Protocol or the CITES Convention can in some instances impact operations. This is also the case for regulations from other countries when import or export of biological material is concerned. Finally, the interaction between some of those regulations is sometimes difficult to interpret and translate into concrete compliant measures.

Xibios offers a wide variety of services in regulatory support:

• exploration of regulatory requirements with respect to projected new operations
• technical advice and guidance on compliance issues (biowaste, transport, import or export...)
• conduction of documented risk assessments as part of notification and authorisation processes
• development and defence of technical positions regarding regulatory requirements
• preparation and defence of regulatory applications
• interaction with Authorities to obtain or renew permits.

The services provided in regulatory support cover most aspects of biorisk management, including specific issues such as gene therapy trials, waste management, transport and transboundary movements of biological materials and biosecurity.