Legal constitution of the Company, including the corresponding inscriptions in the required public registries, an essential step to initiate the proceedings for health regulatory affairs.
Authorization for opening or Authorization of establishments of Importers, Distributors, Production Laboratories, Fractionators, Packers, etc. before dependencies of the Ministry of Public Health and Social Welfare (MSP and BS), National Customs Directorate (DNA), Ministry of Industry and Commerce (MIC), Ministry of Environment and Sustainable Development (MADES), National Directorate of Intellectual Property (DINAPI) and others required.
Elaboration of Architectural Plans of the Establishments by Professionals of the sector, with the required divisions, in accordance with the requirements demanded by the MSP and BS.
Follow-up and general orientation in the different stages of the process of processing the Sanitary Registries (new, renewal, modification) before DNVS and INAN, of the products to be marketed.
Preparation and implementation of the Procedures Manual for Good Storage and Distribution Practices (BPAD), including preparation of Forms, Staff Training and Compliance Records, in accordance with the rules of the World Health Organization (WHO) and current provisions of the Health authorities at the local level (DNVS, INAN).
Processing of Brand Titles of the products to be imported or marketed before the Industrial Property Directorate, dependent on the National Directorate of Intellectual Property (DINAPI).
Accompaniment and guidance to importing Companies for the application at the international level, obtaining and presentation of foreign documentation required locally for the procedures of the Sanitary Registries, according to the items corresponding to the different products to be registered.
Linking with national Laboratories to carry out physical-chemical and biological analyses, which are requested by the health authorities to obtain health records.
Monitoring and guidance of Pharmacovigilance and Control tasks required by the MSP and BS.
Solutions to regulatory conflicts through the intervention of professionals with high solvency and technical-legal experience.
PHARMACEUTICAL SPECIALTIES - MEDICINES
PERSONAL HYGIENE PRODUCTS, COSMETICS AND PERFUMES
HOME SANITARY RISKS I - II
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MEDICAL DEVICES, SHARP MATERIALS AND PERSONAL PROTECTIVE EQUIPMENT
RAW MATERIALS FOR THE PHARMACEUTICAL AND NON-PHARMACEUTIC INDUSTRY
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