Regulatory affairs

The biotechnological products related to human and animal health must meet certain regulatory requirements according to the current national legislation and on the type of product under development.

Sometimes, only paperwork is needed to get the authorization from the regulatory agencies, but in most cases non-clinical and clinical studies will be mandatory to assure the safety and efficacy of the products before their market launch.

Contact us and we will offer you a customized proposal both for occasional consultations or to help you in the establishment and follow-up of a regulatory strategy according to your product’s features.