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Services we provide in Brazil

Regulatory Compliance

Audit of compliance regulatory framework for managing changes in products and processes in light of current legislation.

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Due Diligence

Audit of drug product dossiers and/or processes to verify compliance with the Brazilian legislation.

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Preparation and submission of dossier in CTD format

Instruction, conversion, or preparation of dossier in CTD format, including internal training and provision of templates.

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Technical-scientific translation

Scientific translation of technical documentation or complete dossiers.

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Online training

Regulatory training for regulatory application and specific guides in the company's practice.

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Representation of the international company to ANVISA

Representation of the international company to ANVISA, especially for submission of CADIFA and GMPc.

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New business

Prospection and approximation between Pharmaceutical and Pharmacochemical companies in Latin America and Europe.

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Ongoing Regulatory Support

Multidisciplinary support for the Pharmaceutical and Pharmacochemical industry’s routine.

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Product lifecycle maintenance and management

Assessment and definition of regulatory strategy for drug product lifecycle maintenance and management.

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Project management

Project management and definition of strategies for optimizing company resources.

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Advice on Deficiency Letter Response:

Technical and regulatory evaluation and discussion to define the strategy for Deficiency Letter response.

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Regulatory Assessment

Assessment of compliance with regulations applicable to the regulatory category of the product.

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    Contact

    info@vitapharmaconsulting.com
    Vita Brazil

    T: +55 11 2626 6083/ +55 51 3533-8594 Av. Dolores Alcaraz Caldas, 90 – 8th floor – Praia de Belas - Porto Alegre/ RS , Brazil 90110-180 Porto Alegre

    Vita Portugal

    T: +351 926 109 009 Avenida da República, nº 6, 1 esq - Avenidas Novas. Lisboa, Portugal 1050 191 Lisboa






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