Elaboration and submission of requests for operating licenses and authorizations, and for certifications of good manufacturing practices.
Elaboration and submission of product marketing authorization applications and renewals.
Elaboration and submission of post-registration variation petitions, annual reports and company technical assessment opinions.
Elaboration and updating of labeling texts, and the respective submission of labeling notifications, based on current legislations.
Tailored regulatory trainings and provision of experienced professionals to work temporarily in the regulatory area of your company.
Quality management and implementation of regulatory compliance practices. Reduction of risks and identification of opportunities through evaluations and technical assessments.
We are specialized in regulatory affairs and we aim to simplify the processes of introduction and maintenance of drug product registration in the Brazilian market.
We have been working since 2009 to reduce complexity and circumvent the inherent bureaucracy in regulatory processes with ANVISA.
Our expertise is to optimize the regulatory activities of our clients with predictive and intelligent solutions, aligned with the company’s business strategy.
We anticipate opportunities and reduce risks, as well as we guarantee quality of management in all legal steps with the competent bodies.Pleasure: We are Prisma!