We advise domestic and international companies on the management health registration portfolios, clinical trials and good practices certification processes, as well as on the implementation of HACCP Plans and compliance with health regulations concerning cannabis use. We also assist our clients during regulatory inspections and in administrative sanctioning proceedings.
We have supported leading companies in their entry into and positioning within the Peruvian market —from the design of regulatory strategies to the resolution of disputes related to product commercialization. Our experience includes regulatory advice on distribution model development, regulatory risk prevention, labeling compliance, promotion, pharmacovigilance, and representation before authorities such as DIGESA, INS, DIGEMID and SENASA.
In addition, we assist in the submission of petitions, administrative appeals, oppositions to sanitary registration applications and test data protection applications, always ensuring the confidentiality of the information submitted. Through a multidisciplinary approach that combines legal expertise and pharmaceutical science, we develop innovative strategies and deliver effective solutions to address the sector’s legal and regulatory challenges.
