Regulatory Affairs

Registration and the adequacy of products and companies in Brazil are not easy tasks. The processes are highly regulated and require competences aimed at the interpretation and application of current standards. It is necessary to have the know-how of how to deal with health surveillance agencies, especially with the Ministry of Agriculture, Livestock and Food Supply (MAPA) and with the National Agency of Sanitary Surveillance (Anvisa). Lucky for us, the BMJ Regulatory Affairs team is extremely professional and knowledgeable. We care about how to regulate your business so you do not have to worry about anything else.

Regulatory Intelligence
  • Elaboration of feasibility study for the framing of products against the legislation of the National Agency of Sanitary Surveillance (Anvisa), of the Ministry of Health (MS) and of the Ministry of Agriculture, Livestock and Supply (MAPA).
  • Responses to doubts and interpretations of legal requirements.
  • Previous analysis of advertising material and product labels, verifying possible risks of assessment.
  • Regulatory Risk Analysis (regulatory control / compliance).
  • Auxilio to schedule meetings in Anvisa and Mapa. ​​
  • Mapping of the main legislations that have an impact on the Preparation and monitoring of processes to obtain import and export licenses.
National Health Surveillance Agency - ANVISA
  • Development and monitoring of processes to obtain the Operating Authorization to produce, distribute, import, export, pack, repackage and commercialize medicines, health products, cosmetics, hygiene products and sanitizing products (sanitizers for home use).
  • Of petitions for regularization of pharmacies and drugstores along with the competent bodies of the national health surveillance system.
  • Training and preparation of manuals of good manufacturing practices for inspection and sanitary certification.Protocol of documents.
  • Development of processes of records of specific medicines, herbal medicines, innovative, generic, similar and biological.
  • Elaboration of processes of registration of new foods and ingredients, foods with functional and / or health claim, bioactive and probiotic substances and processes of inclusion or extension of use of food additives and coadjuva technology.
  • Development of registration processes and registration of products for health. Development of registration processes for cosmetics.
Ministry of Agriculture Livestock and Supply - MAPA
  • Document protocol.Follow-up of processes.
  • Auxilio for closer relationship with MAPA stakeholders.Identification of regulatory trends.
  • Development of process for registration of producer establishment.
  • Development of processes for registration of beverages and products of plant, animal origin.
  • For veterinary use, fertilizers, inoculants, correctives and beverages