Regulatory Affairs consultancy

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 above examples also show that the situation is diversified in that the regulation can be relevant for a Country or for a group of Countries. 
While the regulated products varies from one case to the other,   all the regulations include requirements for the quality and safety of the product and – in several cases – also refer to the organisation of the company, that is the management system.

The Regulatory Affairs consultancy has to consider both these aspects.

If your company wants to expande the business and you miss the specialized resources to adequately handle these issues, contact us; we’ll let you know in advance:

– which are the regulatory rules for your products in those markets

– in which way we can help you in the realization of your programs.