Regulatory Affairs

The registration and suitability of products and companies in Brazil is not the easiest task. The processes are highly regulated and require skills 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 a feasibility study for the framing of products in line with the legislation of the National Health Surveillance Agency (Anvisa), the Ministry of Health (MS) and the Ministry of Agriculture, Livestock and Food Supply (MAPA)
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  • Answers to queries and interpretations of legal requirements
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  • Pre-screening of advertising material and product labels to check for potential risk of assessment
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  • Regulatory change analysis / regulatory compliance
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  • Meeting scheduling help with Anvisa and Map
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  • Mapping of key legislations that impact the business
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  • Preparation and follow-up of processes to obtain import and export licenses
National Health Surveillance Agency - ANVISA
     

  • Elaboration and follow-up 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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  • Preparation and follow up of petitions to regularize pharmacies and drugstores with the competent bodies of the national health surveillance system.
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  • Training and development of good manufacturing practice manuals for sanitary inspection and certification

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  • Document Protocol
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  • Elaboration of registration processes for specific, herbal, innovative, generic, similar and biological medicines
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  • Elaboration of processes for the registration of new foods and ingredients, foods with functional and / or health claims, bioactive and probiotic substances and processes for the inclusion or extension of the use of food additives and technology adjuvants
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  • Elaboration of registration processes and registration of health products
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  • Development of registration procedures for cosmetics
Ministry of Agriculture Livestock and Food Supply - MAPA
     

  • Document Protocol
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  • Process follow-up
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  • Relief for closer ties with MAPA stakeholders
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  • Identifying Regulatory Trends
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  • Elaboration of process to register producer establishment
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  • Preparation of registration processes for beverages and products of plant, animal origin; veterinary use; fertilizers; inoculants; correctives and beverages

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