The complete regulatory solution to your business in Brazil.
The Soluto Group is a structured business complex, specialized in regulatory solutions across various sectors. Following the One Stop Shop concept, we offer strategic and operational solutions solutions that demand technical and regulatory expertise. Our extensive experience let us act securely in all workflow chain.
Our main objective is to address regulatory issues with strategic visionadding worth value and protecting our clients through through complete business compliance and regularization de seus negócios.
We develop integrated technical, commercial and operational solutions that encompass different themes, areas and subjects guided by regulatory guidelines.
By using a systemic approachwe ensure an integrated perspective to face our clients´ challenges.
The complete regulatory solution to your business in Brazil.
The Soluto Group is a structured business complex, specialized in regulatory solutions across various sectors. Following the One Stop Shop concept, we offer strategic and operational solutions solutions that demand technical and regulatory expertise. Our extensive experience let us act securely in all workflow chain.
Our main objective is to address regulatory issues with strategic visionadding worth value and protecting our clients through through complete business compliance and regularization de seus negócios.
We develop integrated technical, commercial and operational solutions that encompass different themes, areas and subjects guided by regulatory guidelines.
By using a systemic approachwe ensure an integrated perspective to face our clients´ challenges.
Vision
Being recognized as the premier solution in regulatory services, with widely technical knowledge and strongly committed to using the best practices on the market.
Purpose
Structuring secure and efficient regulatory, technical, and operational solutions to assist individuals and businesses, making a difference in the dynamics of business and society.
Values
- Business throught people
- Deal with our clients’ causes and we contribute to their achievements
- Technical competence and passion to service
- Our enthusiasm inspires people and achieves results
- Transparency builds trust
- Continuous self development
- Ethical values and Compliance are non-negotiable
- Synchronization with the regulated environment
- Regulation is NOT unnecessary bureaucracy
Quality policy
Quality guidelines that guide the philosophy of work in Soluto Regulatórios:
Provide services supported by the intrinsic values of the Company.
Serving customers while respecting their individuality.
Act with integrity, compliance, ethics and legality.
Develop continuous improvement actions in internal processes.
Use management, monitoring and controlling tools.
Structuring the Company's Organizational Culture under the aegis of loyalty, cooperation, transparency and commitment in internal and external relations.
Empower employees in new knowledge and skills.
Encourage the development of new corporate attitudes and skills.
Be our customers' first choice.
Be our customers' first choice.
Our articles
RDC No. 687/2022
New criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices. On 05/18, Resolution - RDC No. 687/2022 was published in the Official Gazette [...]
Changes in the RDCs approved during the pandemic.
Understand what changes in health legislation with the end of the emergency related to Covid-19. Check out some rules extended and revoked by the agency. After the government declared the end of [...]
Regulatory efficiency in the Importation of Essential Medicines via RDC 563 and RDC.
Understand the main criteria of exceptionality, extended by ANVISA until 03/31 to reduce the risk of shortages The international health crisis caused by SARS-CoV-2 and its variants, raised the alert of the sectors connected [...]
Quality Audits
Let's talk about Conducting Quality Audits, an activity that covers several fronts and makes up the portfolio of services offered by Soluto Regulatórios. These are important processes for companies that are already regularized, [...]
