Regulatory Compliance | Preparation | Support

Regulatory Compliance

Our experts and project managers have developed their compliance competencies working for international pharmaceutical laboratories and in the management of numerous compliance projects, in particular the FDA expectations. Today, Validapro have over 70 FDA inspections, all of which have been successfully completed!

Services Overview

  • Analysis of regulatory needs
  • Mock Audits of structures and systems in place on the basis of the relevant regulatory standards
  • Audits of suppliers
  • Reports defining each gap (deviation) in detail, their criticality and corrective actions
  • Action plans | Quality plans and other compliance projects with assessment of resources required and planning
  • Management of compliance programs
  • Implementation of Quality systems and documentary systems
  • Development of procedures
  • Preparation and assistance to audits of the regulatory agencies
  • Remediation Plan

Other services offered

Validapro also offers regulatory compliance services including:

  • Liaison with regulators FDA, EMA, ANSM, ANVISA, Japan et de Health Canada
  • Preparation of establishment licenses, applications for DIN, NPN, DIN-HM, DMF, PMA, 510(k)
  • Support for the management of complaints, non-compliances and recalls
  • Support for the management of responses to the regulatory agencies (Warning letters, 483)


Validapro specialists and experts conduct in-company training sessions in their various areas of expertise, including targeted training on validation and compliance with Good Manufacturing Practices (cGMP). After a theoretical part, Validapro integrates a practical part of application of the concepts tackled on the processes of the client.

Validapro is a certified training organization, all or a part of the service may be supported by your collecting agency (OPCA).