With more than 12 years of experience, serving the main companies in this sector, Soluto Regulatórios offers dynamic, customized and individual operational management, in which technical reliability, procedural quality, response time and ethics make Soluto a reference company in this market.

Regulatory
planning
Company regularization
Product regularization
Start‐up, merger & acquisition and other corporate movements
Support importing and exporting processes
Post-registration regulatory management
License Management / GMPs
Post-market Surveillance Management

Regulatory Solutions

Strategic regulatory planning and implementation

  • Strategies assessments for the projects
  • Simulation of deadlines and investments
  • Feasibility analysis
  • Structured execution with project management
  • Interface with stakeholders for meeting deadlines
  • Rigid discipline in customer communication

Dynamics regarding submitted processes

  • Protocol of proceedings with ANVISA
  • Management of filed processes
  • Periodic follow-up with the customer
  • Interaction with the regulatory agency
  • Regulatory management