Regulatory Compliance Management

Pharma organizations across the globe are compelled to alter their compliance practices to conform to changes in regulations and stringent anti-corruption laws. All regulatory activities across the globe requires pharma & life sciences companies to identify quality issues ensuring patient safety. Navitas Life sciences provides a vast array of Regulatory Quality services:
Compliance
  • Conduct CAPA and address Deviations on time
  • Audit Readiness Assessment
  • Conduct and support Internal Audits, External Audits, Mock Audits and ISO Audits
  • Quality Management System (QMS) reporting
  • Quality Risk Management review
  • IT Systems Implementation and Documentation
  • Monitor and ensure Global Quality Compliance
Procedures and Working Instructions
  • Managing the review of Regulatory global and local SOPs on time
  • Provide support to create working instructions for non-GxP processes
  • Support Records Management Role
Training
  • Provide and maintain GMP documentation as per your corporate quality standards – from onboarding to continuous learning development
  • Develop on-boarding programs with relevant training modules
Project Management Support
  • Lean setup of training activities
  • Technical contribution to project team or sub-teams
  • Change Control Management
  • Support operational excellence initiatives