Harpia Medical

Harpia Medical is a company highly specialized in regulatory intelligence. It supports Medvacca Brasil in matters that require indepth analysis of the Brazilian regulatory scenario. The national regulatory environment is constantly changing. Harpia Medical is constantly updating itself and looking for new solutions to keep up with these changes. In addition to regulatory expertise, the company acts as a marketing advisor for international clients, selecting products consistent with Brazilian demands, evaluating government purchases to analyze domestic market trends, and conducting price research to analyze the financial feasibility of products.

Market

Market analysis, assessing the economic, legal and competitive scenario for each product.
Selection of products by degree of feasibility based on data.

Regulatory register

Composition of dossiers for drugs and health products in accordance with ANVISA regulations.
Evaluation of documentation sent by manufacturers and expedition of gap analysis of information necessary for registration.
Follow-up of the registration process until publication in the official journal and postmarket follow-up (pharmacovigilance).

Certification

Hiring certifiers and assessing the conformity of health products in entities such as INMETRO and INCQS.
Equipment testing in the laboratory to verify compliance with technical standards.
Advice for factories abroad for certification in GMP Certification by ANVISA, including preinspection of the production line to be certified with identification of requirements to be met and any non-conformities.