The regulated system requires stakeholders to be formally qualified and periodically audited by the Quality Management System. Soluto Regulatórios supports companies developing structured programs, considering the necessary guidelines for each business in terms of Quality, Health, Safety and Environment requirements. The program is structured as follows:

  • Definition of prerequisites according to the contracted (or to be contracted) object, respecting the technical guidelines assigned for each business segment, class of product and service
  • Remote and in-loco audits
  • Development of control and monitoring plan of stakeholders

Certification of Good Practices

The Brazilian Sanitary Legislation determines that manufacturers, importers and distributors of products regulated by ANVISA must follow the guidelines of Good Practices, governed by specific regulations. The regulated agent must have a Quality Management System model focused on guarantee, quality and safety of the product, from production preparation to effective availability to final costumer. Soluto Regulatórios supports and guides companies in this process through the following strategy:

  • Pre-project audit to assess the current position of companies comparing to legal requirements
  • Structuring the regulatory project to adjust non-compliances
  • Mapping operational processes to define new procedures
  • Implementation of new established procedures
  • Internal audit to verify compliance and validation of Good Practices
  • Prior Inspection Audit for the Certification of Good Practices
  • Monitoring of the certification audit process of companies, carried out by the certifying body

Maintenance of the regulated system with focus on Quality Assurance

Companies legalized by the Regulatory Agencies must maintain compliance within their documents. Licenses, Authorizations, Registrations, Registrations, Certificates and other specific legal documents in each business activity require periodic updates, revisions, renewals and revalidations.

These documents are required by the inspection agent at each Agency or Regulatory Body, together with documentary evidences regarding compliance with the Quality Program and established operational procedures.

A Soluto Regulatórios acts in order to guide and instruct companies on how best to keep the compliances required by the regulated system, avoiding interdiction, fines and damages resulting from the non - renewal of licenses, permits or certifications.