With extensive regulatory experience in pharmaceutical company licensing, our project management allows us to operationalize all activities in a safe, dynamic, customized and individual way, where technical reliability, commitment, procedural quality, response time and ethics make Soluto a reference company in regulated market.

Company regularization

  • Operating authorizations by ANVISA
  • Certification of good practices by ANVISA
  • Licensing by the Health Surveillance
  • Architectural projects and LTA's (technical reports)
  • Licensing by civil police, federal police and army
  • Environmental licensing
  • Permit and municipal declarations
  • Class council certificates

Regulatory management

  • Control of deadlines and obligations
  • Licensing Renewals
  • Fulfillment of ancillary obligations
  • Maps reporting controlled products consumption
  • Petition for contracts with third parties

Import support

  • NCM suggestion
  • ANVISA annual import quota
  • ANVISA import consent
  • Obtaining free sale certificate
  • Regulatory interface with dispatchers
  • Import process management

Strategic regulatory planning and implementation for corporate transactions, start-up, Merger & Acquisition movements

  • 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 before the competent bodies
  • Management of filed processes
  • Periodic follow-up with the customer
  • Interaction with the regulatory agency
  • Regulatory management