The biotechnological products related to human or animal health must comply with a series of regulatory requirements in accordance with the legislation in force in each territory and based on the type of product being developed.
On some occasions it is only necessary to carry out bureaucratic procedures with the regulatory agencies, but in most cases animal studies as well as clinical trials must be developed to corroborate the safety and efficacy of the products before their launch on the market.
It is important to determine the applicable regulatory framework for each specific product, in order to develop a realistic project plan, in terms of time and costs.
In addition, in most cases, it is recommended that scientific advice with the competent regulatory agency of the territory where we want to register our product, and in the case of drugs targeting rare diseases, we must apply as soon as possible for orphan drug designation.
Contact us and we will offer you a personalized proposal for any specific consultation or to count on us for the development and monitoring of a regulatory strategy according to the characteristics of your product.