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