REgulatory Affairs
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Market entry research for products with other Indications and Usages, concerning government and business markets.
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Submission procedures to the sanitary agencies for registrations, certificates, licenses and other authorizations to import, export, manufacturing and distribution of any kind products.
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Dossiers preparation for presentation of technical documentation for a variety products required by authorities and application for regulatory authorizations.
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Observations of verification processes and assistance on sanctions or irregularities cases in the production phase.
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Communication management for effective exchanges of information between regulatory authorities and companies within all organizational levels.
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Advertising and labeling consulting, as well as submissions procedures to specific product advertising authorizations by the sanitary authority.
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Management structure and systems, evaluation of manufacture plants for a variety of products which includes documentary examination, facilities and installations inspection, footprint optimization, machinery and equipment, as well as the preparation of analysis of risk and design of critical.
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Regulatory affairs and compliance training, both face-to-face and remote meetings, as well as preventive actions, continuous improvement processes and regulatory updates.
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