EBSA Corporate members
PERSEUS offers efficient solutions for biorisk management and compliance with the complex biosafety and biotechnology regulations.
Biorisk management covers all aspects of biological safety and security such as inventory management, risk assessment, containment and confinement requirements, training, audit, transport, waste handling and emergency preparedness.
PERSEUS integrates technical background with an in depth knowledge of the European regulatory requirements for biological material, including genetically modified organisms. We assist clients in complying with complex regulatory requirements on contained use, workers protection, pathogens, import and export, emergency planning, deliberate releases such as field trials and clinical trials and commercial applications.
We have a proven track record in advising on design, following up construction and commissioning, and managing biological safety and operations of up to biosafety level 3 facilities. Such facilities include research laboratories, large-scale production plants, clinical, hospital and gene therapy settings, as well as plant and animal bio-containment facilities. For genetically modified material, PERSEUS offers extensive expertise in all life cycle phases, including those that extend beyond containment (e.g. field trials, commercial applications, movement of materials and imports).
Some examples of tasks performed by PERSEUS:
- Obtaining, defending and maintaining permits for operations and products
- Setting up routines for as well as performing risk assessments
- Providing technical guidance and regulatory support on transportation and importation
- Implementing compliance systems and interacting on compliance issues
- Assisting the integration of biosafety in organization's management systems
- Advising on facility planning and construction, on exposure control and emergency response
- Advising waste management of biologicals
- Providing information on biosafety practices, protective equipment and special service providers
- Training and advising on communication, including crisis communication
- Supporting advocacy efforts related to regulatory developments
Focusing on Europe (including Russia and Eastern Europe), a network of PERSEUS Associates ensures geographical coverage and access to EU member state authorities. Furthermore, PERSEUS is linked to service providers in other regions enabling the full range of international and worldwide regulatory activities.
Contact information: PERSEUS bv ▪ Kortrijksestenweg 127, B-9830 Gent, Belgium; Tel +32(0)475/45.72.04 ▪ Fax +32(0)9/321.07.05