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Regulatory Affairs

Barral M Jorge Consultores Associados – BMJ is a company specialized in providing consulting services in International Trade, Government Relations and Investment Projects founded in 2011 by Miguel Jorge, former Minister of Development, Industry and Foreign Trade, and Welber Barral, Former Secretary of Foreign Trade.

Barral M Jorge, thinking about improving the performance of its clients, has just launched a new area within its portfolio: Regulatory Affairs

Commitment

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  1. Feasibility analysis for the framing of products against Brazilian sanitary legislation
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  3. Answers to doubts and interpretations of legal requirements
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  5. Prior analysis of advertising material of the company to verify possible risks of assessment against the current health legislation
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  7. Prior evaluation of label layout against the presence or absence of mandatory items according to current health legislation
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  9. Regulatory Risk Analysis (change control / regulatory compliance)
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  11. Assistance to comply with the requirements of the National Sanitary Surveillance Agency (Anvisa) and the Ministry of Agriculture, Livestock and Food Supply (Map)\r\nAssistance for scheduling meetings at Anvisa and on the Map\r\nRegulatory feasibility analysis for post-registration changes or renewal of registration of products with Anvisa or Map
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Registration, Qualification, Adequacy, Licensing and Authorization of Companies

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  1. Registration and authorization of establishments for International Trade
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  3. 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 household sanitizers (sanitizers for home use)
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  5. Preparation and monitoring of petitions for regularization of pharmacies and drugstores with the competent bodies\r\nPreparation and follow-up of processes to obtain
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  7. Certificates of Good Manufacturing Practices and Quality Control of companies from the competent sanitary bodies, includes advice on the revision and / or elaboration of the Manual of Good Practices and Standard Operating Procedures, as well as their practical application And systems of self-inspection, validation of processes, procedures and method before inspection by the sanitary authority
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  9. Elaboration of petitions for company registration and update of the economic size with Anvisa
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Registration and Internalization of Products Next to the Regulating Bodies

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  1. Preparation and monitoring of product registration processes in Anvisa, the Ministry of Health and the Ministry of Agriculture, Livestock and Supply
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  3. Assistance to obtain the Federal Inspection Service
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  5. Preparation and follow-up of processes to obtain import and export licenses, export authorization certificate, import quota for psychotropic substances and narcotics and import guide authorization for health products and equipment
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  7. Elaboration and follow-up of the process for Inclusion of Exceptional, High Cost Medicines and Specific Programs in the Unified Health System (SUS)
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  9. Monitoring of prices in the Market of Regulation of the Medicines Market – CMED
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Latest news

Por que a liberação de emagrecedores pelo Poder Legislativo ameaça o SUS e o setor farmacêutico brasileiro?

10 de August de 2017 em Regulatory Affairs | Boletim BMJ

A vacina da febre aftosa e seu impacto na economia brasileira

28 de July de 2017 em Regulatory Affairs | Boletim BMJ

BMJ lança edição de julho do Boletim BMJ

8 de July de 2017 em Regulatory Affairs | BMJ