A Pro Consult

Consulting services on regulatory compliance in Life Sciences-Healthcare and Data Privacy Regulatory Compliance in Life Sciences-Healthcare -Analysis of the need to regularize the business and products at ANVISA -Regulatory strategy for the introduction and maintenance of products subject to ANVISA regulation – pharmaceuticals, Cannabis products, cosmetics, medical devices, food supplements -Product classification and risk assessments -Regulatory risk management; Gap analysis and risk-assessments -Consultations/Opinions -Interaction with the Regulatory bodies -Preparation of dossiers, submission of market authorization and follow-up until approval -Analysis of Marketing strategies from a legal/regulatory point of view -Analysis of contracts (manufacturing, outsourcing, quality control, distribution, warehousing, research & development and licensing) Data Privacy/Data Protection -Guidance and support for creation of a Data Privacy Program/Privacy governance – Consultations and opinions related to privacy/data protection – Analysis and preparation of documents: contracts, contractual clauses, privacy policies and other instruments – Third-party management: support to the data controller/processor in the management of processors/sub-processors – Management of data subjects’ rights: support to the controller – Training and qualification of employees, partners and service providers in relation to the programs and developed policies. – Management of administrative procedures at the ANPD (National Authority for Data Protection) in Brazil.