We advised our client with respect to the applicable sanitary regulations for the commercialization of protection-safety glasses. The assessment included the analysis of the different scenarios that could emerge due to the liability of the company in the commercialization of the mentioned products and regarding its use in different economic activities of the country. That implied that a broad regulatory analysis to solve the consultation and the liability limitations. 

We advised our client regarding the renewal proceeding of the Certificate of Good Storage Practices and the strategy to be followed while renewal process is in progress, since the authority executed attachment measures of temporary closure of its storage facilities. In this sense, the case was complex as there were certain irregularities in the inspection proceeding conducted by the sanitary authority. Our team designed a sophisticated strategy to advert the authority of such inconsistencies.  

We are currently providing assistance to Pharmaris in the execution of a contract of a Public Tender with the Peruvian government. Pharmaris was requested to perform a mass delivery of the product prior to the delivery date established in the contract as a consequence of the urgent need expressed by the entity. Notwithstanding, the corresponding conformity certification of the product was at that moment being matter of analysis by the authorized laboratory. After some short period of time, the laboratory finally expressed the non-conformity of the product. Our assessment implied a complex regulatory analysis, and the team provided legal advice with respect to the recall of the products and the mitigation actions related to the possible sanctions that could be imposed by the sanitary authority.  

We provided assistance to Draeger Peru regarding and administrative sanctioning proceeding for spare parts of medical devices. In this case, the competent regulatory authority (DIGEMID) took an arbitrary position, and our defence consisted of demonstrating the legality of obtaining the sanitary registration and the compliance with the applicable regulations. The case has been complex since it involved the deep understating of the functioning of the medical devices that were questioned, and the special regulation applicable to such devices. For this effect, we had to work directly with the technicians’ experts of the client, to describe the exact composition of the parts objected by the authority, its functions on the equipment, determine if they could be considered as perishables parts or not, or if they are just replacements of the equipment. With that analysis we were able to structure the position and defence of our client. This was a case without much prior pronunciations of the authority, and in that sense imply not only a defence argument position, but also an explanation of the equipment, parts, and functionality, from a legal perspective supporting our position    We have also represented our client in the hearing held to defend our position, with favourable results.   The case is pending to be resolved.