Solutions

Explore our portfolio of services.

Regulatory Consulting

Pharmaceuticals
Consumer Health Products
Healthtechs

Data Privacy

Data Protection Governance

Healthcare professionals

Clinics and offices

Regulatory Consulting on Pharmaceuticals, Consumer Health Products, Healthtechs

Analysis of the need to regularize the business and products at ANVISA (Pharmaceuticals, Cannabis Products, Cosmetics, Medical Devices, Food Supplements).
Assistance on the search for ‘Marketing Authorization hosts’ or business partners in Brazil.
Regulatory strategy for the introduction and maintenance of products subject to ANVISA regulation:
  • Product classification and risk assessments
  • Regulatory risk management
  • Gap analysis and risk-assessments
  • Interaction with the Regulatory bodies
  • Analysis of Marketing strategies from a legal/regulatory point of view

 Legal/Regulatory Opinions

Analysis of contracts (manufacturing, outsourcing, quality control, distribution, warehousing, research & development and licensing).

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Data Privacy/Data Protection Governance

Guidance and support for creation of a Data Privacy Program and Privacy governance.

Consultations and Legal/Regulatory Opinions related to privacy and 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.

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Healthcare professionals (offices/clinics)

Data Protection in Healthcare: Implementation of data protection governance in Clinics and Offices.

Management of administrative procedures at the ANPD (National Authority for Data Protection) in Brazil.

Telemedicine and telehealth: contracts and best practices.

Partnership agreements between healthcare professionals.

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