Biosafety is a specific field of expertise that appears transversal to most research, development or production activities involving biological material. It is a highly specialised and somewhat eccentric part of the management of health, safety and environment that involves regulatory aspects, facility planning and management, operational processes, work organisation and practices, and human behaviour.
Depending on your role in your company or institution, you may be confronted at various degrees to different aspects of biosafety, and may therefore encounter particular needs. You may for instance recognise yourself in one of the following scenarios.
- You run a biotech or biomedical company or institution and want to set up a compliant, effective and sustainable biorisk management programme, or you want to up-date or improve your existing programme.
- You manage research, diagnostic or manufacturing operations and want to assess the performance of the biosafety measures or procedures in place, as part of good governance or in preparation for a specific inspection or audit.
- You plan to build, expand or renovate biological laboratories or manufacturing premises and want to make sure your future biocontainment facilities will not only be adapted to your operations but also fully compliant and a basis for efficient and safe work practices.
- You are an architect or an engineer in charge of the planning and construction of biocontainment facilities and want to make sure that your interpretation of your customer's requirements is appropriate and that your project will meet all the scientific and operational needs together with the safety and biosafety requirements.
- You are responsible for biological safety or for health, safety and/or environment at your institution or company and would require specialised advice in specific areas of biosafety such as biological risk assessment, work practices including disinfection processes and biowaste management, emergency planning, biosecurity or transport of biological material.
- You are a biosafety officer, possibly also in charge of other responsibilities, and would need some additional support to ensure the training of the personnel of your institution or carry out other time-consuming tasks that are part of a biosafety programme.
- You would like to know the impact of a new regulation on your operations or know how to comply in the most pragmatic way.
- You are in charge of regulatory affairs, mainly dealing with product and product quality issues, and want to guarantee an optimal presentation and/or defence of your biosafety dossiers to the authorities…
If you recognise yourself in one of these scenarios or in another situation where you would need specialised support in biosafety, please do not hesitate to contact us to explore possible solutions.