Regulatory Compliance

Regulatory Compliance | Preparation | Support

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)

Training

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).