Areas of expertise
Development of human and veterinary medicinal products
Developers of medicinal products manage closely the sequence of pre-clinical and clinical trials in order to achieve critical project milestones.
When these products have been obtained via genetic engineering, then also the European GMO legislation for protecting the environment is applicable.
During research and development the GMO contained use legislation must be adhered to by production and formulation sites as well as by clinical trial centres. In addition, depending on the EU Member State and the specifics of the clinical trial, the GMO deliberate release legislation may be applicable.
Finally, when applying for Marketing Authorization, all the elements allowing a full environmental risk assessment need to be submitted.
We support developers and CROs in addressing the specific needs of the GMO legislation in different EU Member States. With our help you can avoid important delays, undesired changes in protocol conflicting conditions, abandoning of clinical trial sites and wasting time on less-receptive Member States.
In function of the environmental risk assessment required for GMOs, we can support you with extending data gathering during the development phase.