Studio tau – Regulatory Affairs
Studio tau has specific competences for Regulatory Affairs consultancy, an expression that refers to the fulfillment of regulations needed to introduce a product on a specific market; these include
– technical rules, focused on the safety aspects and quality of the products, as well as on the company organization
– administrative rules, defining the ways in which companies interacts with the Authorities in charge.
Focusing on the technical aspects, we remember some meaningful regulation examples:
– the movements of goods in Europe is free but the products must comply with the applicable European Directives and Regulations
– the export of different products to the United States of America is regulated at federal level; products like foods, medicines and medical devices are subjet to the FDA approval
– for several categories of products, access to Russian and other EAEU countries markets shall comply to the rules agreed in the frame of this agreement.
In some cases – e.g. in the Gulf area where the G-Mark applies to electrical products – regulations are much similar to the European ones; in other – like the Mercosur in Southern America – customs clearance agreements do not involve the harmonization of the technical regulations.
The Regulatory Affairs consultancy has to consider both these aspects.
– which are the regulatory rules for your products in those markets
– in which way we can help you in the realization of your programs.